Estímulos Sensoriais Durante o Parto por Cesárea: Um Estudo de Coorte Longitudinal (PIONEER-MC)
29 de julho de 2026 atualizado por: Juliana Barrera, University of British Columbia
Perceção do Paciente de Estímulos Sensoriais Durante Cesarianas Eletivas sob Anestesia Neuraxial (PIONEER): Um Estudo de Coorte Longitudinal.
Este estudo irá acompanhar pessoas que têm um parto por cesariana planeado com anestesia raquidiana ou combinada raqui-peridural. Vamos perguntar que tipos de sensações sentem durante a operação, com que frequência estas ocorrem e se alguma das sensações é considerada inaceitável ou demasiado desconfortável.
Serão feitas algumas perguntas curtas aos participantes em seis momentos definidos durante a cirurgia. Também irão preencher questionários curtos antes da cirurgia e novamente após o parto (até 6 meses) para nos ajudar a compreender o humor, o stresse e o bem-estar geral.
Visão geral do estudo
Status
Status
Recrutamento
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
O parto por cesariana é comum e a anestesia neuroaxial é a técnica padrão; no entanto, uma proporção significativa de pacientes experiencia dor intraoperatória ou sensações angustiantes. A investigação existente baseia-se frequentemente em recordações retrospectivas, marcadores substitutos (por exemplo, uso de medicação) e definições variáveis de dor intraoperatória, com uma caracterização prospetiva limitada das experiências sensoriais que os pacientes percecionam e se as interpretam como dolorosas ou de outra forma inaceitáveis.
O PIONEER é um estudo prospetivo de coorte longitudinal que recruta pacientes grávidas saudáveis submetidas a parto por cesariana eletivo no Hospital BC Women's. O principal objetivo é estimar a incidência de estímulos sensoriais intraoperatórios que são auto-reportados como inaceitáveis (ou seja, sensações que o participante relata como inaceitáveis e que necessitam de tratamento). Os dados intraoperatórios serão recolhidos em seis marcos cirúrgicos definidos, desde a confirmação do bloqueio até ao encerramento da pele, através de perguntas curtas ao paciente. O seguimento pós-operatório e longitudinal avaliará o sofrimento pós-parto, a depressão e os sintomas de TEPT. Os cuidados clínicos não são dirigidos pelo estudo; a gestão anestésica e cirúrgica permanece ao critério da equipa de tratamento.
Tipo de estudo
Tipo de estudo
Observacional
Inscrição (Estimado)
Inscrição
1005
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
Contato de estudo
- Nome: Juliana Kruthof, MD, MSc, FRCPC
- Número de telefone: 6335 604-875-2424
- E-mail: juliana.barrera@cw.bc.ca
Locais de estudo
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British Columbia
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Vancouver, British Columbia, Canadá, V6H3N1
- Recrutamento
- BC Women's Hospital
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Contato:
- Juliana Kruthof, MD, MSc, FRCPC
- Número de telefone: 6335 604-875-2158
- E-mail: juliana.barrera@cw.bc.ca
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Contato:
- Simon Massey, FRCA, FRCPC
- Número de telefone: 6335 604-875-2158
- E-mail: simon.massey@cw.bc.ca
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Subinvestigador:
- Roanne Preston, MD, FRCPC
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Investigador principal:
- Juliana Kruthof, MD, MSc, FRCPC
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Subinvestigador:
- William Shippam, MBChB, FRCA, FRCPC
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Subinvestigador:
- Kathryn Clark, MD, FRCPC
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Subinvestigador:
- Katherine M Seligman, MD, FRCPC D.ABA
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Subinvestigador:
- Simon Massey, FRCA, FRCPC
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Grávidas saudáveis ≥36 semanas de idade gestacional submetidas a cesariana eletiva sob anestesia neuraxial no BC Women's Hospital
Descrição
Critérios de Inclusão:
- Pacientes grávidas saudáveis com ≥36 semanas de idade gestacional
- Classe de Estado Físico ASA 2-3
- Parto por cesariana eletiva
- Idade ≥19 anos
- Falantes de inglês
Critérios de Exclusão:
- História conhecida de dor crónica ou distúrbios de dor
- A tomar atualmente medicamentos com propriedades analgésicas
- História conhecida de condições neurológicas que possam prejudicar a sensação normal
- Parto por cesariana que exija reforço de epidural ou anestesia geral de novo
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Número de grupos/coortes
1
Coortes e Intervenções
Grupo / CoorteGrupo / Coorte |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Elective cesarean delivery under neuraxial anesthesia
Adults undergoing a planned (elective) cesarean delivery under single-shot spinal or combined spinal-epidural anesthesia at a participating tertiary-care obstetric center.
All enrolled participants form a single prospective cohort and undergo the same study assessments: standardized self-report of intraoperative sensory experience at six predefined surgical timepoints (including, at each timepoint, whether a sensation is felt, a verbatim description of the sensation, a request for intervention if any, an intensity rating, and the anatomical location of the sensation), followed by longitudinal psychological assessment from a preoperative baseline through 6 months postpartum.
Participants are not assigned to any intervention or exposure by the investigators; all anesthetic and surgical care is provided by the clinical team according to institutional standards.
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The exposure of interest is the participant's own request, made during cesarean delivery, for the clinical team to provide a pharmacological intervention in response to an intraoperative sensory stimulus.
At each of six predefined surgical timepoints, participants who report a sensation are asked whether they would like the team to act and, if so, whether they are requesting medication, some other action, or both.
A request that includes medication constitutes the exposure.
This is an observed, patient-initiated event; investigators do not assign or administer it, and all clinical management remains at the discretion of the treating team.
This exposure is linked to the single study cohort (Elective cesarean delivery under neuraxial anesthesia).
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
Prazo: Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test (immediately before skin incision) through skin closure during the cesarean delivery (typically up to approximately 90 minutes)
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At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), participants who report a sensation are asked: "Is there anything you would like us to do to address the sensation, like giving you medication or some other action?"
A participant meets the outcome if, at one or more timepoints, the request includes medication (alone or together with some other action).
Requests for some other action only, and timepoints with no affirmative response, are counted as non-events.
The measure is the proportion (percentage) of participants with at least one qualifying request: the numerator is participants requesting a pharmacological intervention; the denominator is all analyzable participants.
Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
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Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test (immediately before skin incision) through skin closure during the cesarean delivery (typically up to approximately 90 minutes)
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Thematic Categories of Patient-Reported Descriptions of Intraoperative Sensory Experiences
Prazo: Intraoperative; verbatim descriptions collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Verbatim responses to the standardized open-ended prompt "How would you describe the sensation you are feeling?",
administered at each of six predefined surgical timepoints to participants who report a sensation, are analyzed by inductive qualitative content analysis.
Sensory categories are derived inductively from participants' own descriptions rather than predefined classifications.
Two independent investigators develop and refine a codebook through iterative open coding; inter-rater reliability is assessed on a random subset using Cohen's kappa (prespecified threshold 0.70) before full coding.
The outcome is the set of thematic categories of intraoperative sensory experience, reported with the frequency of each category and its distribution across the six surgical timepoints.
Reported per the Standards for Reporting Qualitative Research (SRQR).
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Intraoperative; verbatim descriptions collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Incidence of Each Type of Patient-Reported Sensory Experience at Each Surgical Timepoint
Prazo: Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), participants report whether they feel any sensation.
Sensory categories are derived inductively from participants' own verbatim descriptions rather than predefined classifications (see the qualitative content analysis).
For each surgical timepoint, the incidence of any reported sensation and of each inductively derived sensory category is calculated as the proportion (percentage) of participants reporting that sensation.
Site-specific proportions are estimated with 95% Clopper-Pearson exact confidence intervals and pooled across participating centers using a DerSimonian-Laird random-effects model on the logit scale, with back-transformation to the proportion scale.
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Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Intensity of Patient-Reported Intraoperative Sensation Measured on a 100-mm Visual Analog Scale at Each Surgical Timepoint
Prazo: Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Participants who report a sensation at a given surgical timepoint rate its intensity on a 100-mm horizontal Visual Analog Scale (VAS), anchored at the left end by "no sensation" (0 mm) and at the right end by "worst imaginable sensation" (100 mm); higher scores indicate greater intensity.
The score is the distance in millimeters from the left anchor to the participant's mark (continuous, range 0 to 100 mm).
Intensity is assessed at each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure).
For each timepoint, VAS scores are summarized within each participating center as medians with interquartile ranges and pooled across centers by random-effects meta-analysis.
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Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Anatomical Distribution of Patient-Reported Intraoperative Sensations Recorded on a Standardized Body Diagram at Each Surgical Timepoint
Prazo: Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Participants who report a sensation at a given surgical timepoint indicate its location on a standardized body diagram.
Each marked location is coded to a set of predefined anatomical regions specified a priori in the body-diagram coding key.
At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), the outcome is the proportion (percentage) of participants reporting sensation in each anatomical region.
Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model on the logit scale, with back-transformation to the proportion scale.
Distributions are additionally cross-tabulated by sensory category and by surgical timepoint to describe spatial and spatiotemporal patterns.
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Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Temporal Pattern of Patient-Reported Intraoperative Sensations Across the Six Surgical Timepoints
Prazo: Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Using the timepoint-specific sensory data, the distribution of reported sensations is examined across the six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure) to characterize how the incidence and intensity of sensation change over the course of surgery.
The outcome identifies the surgical timepoint(s) associated with the highest incidence of patient-initiated requests for pharmacological intervention and the highest median Visual Analog Scale intensity among reported sensations.
Patterns are determined within each participating center and at the pooled level (DerSimonian-Laird random-effects model) to evaluate consistency of the temporal pattern across centers.
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Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Proportion of Non-Pain Sensory Stimuli That Prompted a Patient Request for Pharmacological Intervention
Prazo: Intraoperative; sensory events and associated requests collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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This event-level outcome quantifies the extent to which sensations not explicitly described as painful nonetheless prompted a patient-initiated request for pharmacological intervention.
Each reported sensory event (across all six surgical timepoints) is classified by the participant's own verbatim description as pain or non-pain (e.g., pressure, pulling, visceral sensation) using the inductively derived sensory categories.
Among events not described as painful, the outcome is the proportion (percentage) that prompted a request for pharmacological intervention, analyzed by sensory category and by surgical timepoint.
Unlike the patient-level primary outcome, this measure operates at the level of individual sensory events.
Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
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Intraoperative; sensory events and associated requests collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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Concordance Between Patient-Initiated Requests for Pharmacological Intervention and Receipt of Supplemental Intraoperative Analgesia
Prazo: Intraoperative; requests and analgesia administration recorded across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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For each participant, patient-initiated requests for pharmacological intervention are compared with the supplemental intraoperative analgesia actually administered by the clinical team (recorded by drug, dose, and route).
The outcome comprises three measures, each reported as a proportion (percentage): the overall concordance rate (agreement between request and subsequent administration); the rate of unmet requests (a request not followed by administration of analgesia); and the rate of unsolicited analgesia administration (analgesia given without a preceding patient request).
All clinical management decisions rest with the treating clinician; the research team records only the request and the intervention provided.
Site-specific rates are pooled across participating centers using a DerSimonian-Laird random-effects model.
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Intraoperative; requests and analgesia administration recorded across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
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PTSD Checklist for DSM-5 (PCL-5) Total Score at Each Assessment Timepoint
Prazo: Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
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The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of post-traumatic stress symptoms.
Each item is rated 0 ("not at all") to 4 ("extremely"), yielding a total score from 0 to 80; higher scores indicate greater symptom severity.
At baseline, participants rate symptoms over the past month; at postpartum timepoints they reference the cesarean delivery as the index event.
The total score is reported at each of five assessment timepoints: preoperative baseline, 24 to 48 hours postpartum, 6 weeks, 3 months, and 6 months postpartum.
Scores are summarized within each participating center, and longitudinal trajectories are modeled using mixed-effects models with site-specific parameters pooled across centers by a DerSimonian-Laird random-effects model.
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Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
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Edinburgh Postnatal Depression Scale (EPDS) Total Score at Each Assessment Timepoint
Prazo: Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
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The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure that screens for depressive symptoms in the perinatal period.
Each item is scored 0 to 3, yielding a total score from 0 to 30; higher scores indicate greater depressive symptom severity.
The total score is reported at each of five assessment timepoints: preoperative baseline, 24 to 48 hours postpartum, 6 weeks, 3 months, and 6 months postpartum.
Scores are summarized within each participating center, and longitudinal trajectories are modeled using mixed-effects models with site-specific parameters pooled across centers by a DerSimonian-Laird random-effects model.
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Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
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Peritraumatic Distress Inventory (PDI) Total Score at 24 to 48 Hours and 6 Weeks Postpartum
Prazo: 24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days)
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The Peritraumatic Distress Inventory (PDI) is a 13-item self-report measure of emotional distress experienced during and immediately after a traumatic event.
Each item is rated 0 ("not at all true") to 4 ("extremely true"), yielding a total score from 0 to 52; higher scores indicate greater peritraumatic distress.
The total score is reported at two assessment timepoints: 24 to 48 hours postpartum (acute peritraumatic distress, the primary peritraumatic measure) and 6 weeks postpartum (recalled peritraumatic distress).
The two administrations are analyzed independently as related but distinct constructs.
Scores are summarized within each participating center and pooled across centers by a DerSimonian-Laird random-effects model.
The PDI is not administered at baseline, as peritraumatic distress by definition relates to a specific event.
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24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days)
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Proportion of Participants Exceeding Validated Clinical Thresholds on the PCL-5, EPDS, and PDI at Each Postpartum Assessment Timepoint
Prazo: PCL-5 and EPDS: 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum. (up to a maximum of 183 days) PDI: 24 to 48 hours and 6 weeks postpartum (up to a maximum of 42 days).
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At each postpartum assessment timepoint, the outcome is the proportion (percentage) of participants whose scores exceed validated clinical thresholds on each instrument: PCL-5 of 31 or higher (probable PTSD; scale 0 to 80), EPDS above 10 (depression risk; scale 0 to 30), and PDI of 15 or higher (significant peritraumatic distress; scale 0 to 52).
On all three instruments, higher scores indicate greater symptom severity.
PCL-5 and EPDS thresholds are assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum; the PDI threshold is assessed at 24 to 48 hours and 6 weeks postpartum.
Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
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PCL-5 and EPDS: 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum. (up to a maximum of 183 days) PDI: 24 to 48 hours and 6 weeks postpartum (up to a maximum of 42 days).
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Association Between Patient-Initiated Requests for Pharmacological Intervention and Exceeding Clinical Thresholds on the PCL-5, EPDS, and PDI
Prazo: Psychological thresholds assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum (PDI at 24 to 48 hours and 6 weeks only), in relation to the intraoperative primary outcome (up to a maximum of 183 days)
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This outcome evaluates whether participants who made a patient-initiated request for pharmacological intervention during surgery (the binary primary outcome) are more likely to exceed validated clinical thresholds on the psychological instruments postpartum: PCL-5 of 31 or higher, EPDS above 10, and PDI of 15 or higher.
Within each participating center, the association is estimated using multivariable logistic regression adjusted for three prespecified confounders (dermatomal level of sensory block, number of previous cesarean deliveries, and preoperative STAI-6 score).
Site-specific adjusted odds ratios are pooled across centers using a DerSimonian-Laird random-effects model and reported as pooled adjusted odds ratios with 95% confidence intervals at each postpartum timepoint.
This analysis is exploratory and hypothesis-generating.
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Psychological thresholds assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum (PDI at 24 to 48 hours and 6 weeks only), in relation to the intraoperative primary outcome (up to a maximum of 183 days)
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Preoperative Anxiety (STAI-6) and Its Association With Intraoperative Sensory Outcomes and Patient-Initiated Treatment Requests
Prazo: STAI-6 measured at preoperative baseline (day of surgery); intraoperative sensory outcomes assessed across the six surgical timepoints during the cesarean delivery (up to a maximum of 1 day)
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Preoperative anxiety is measured once at baseline using the 6-item State-Trait Anxiety Inventory short form (STAI-6).
Each item is rated 1 to 4; the raw total (6 to 24) is multiplied by 20/6 to give a transformed score on the standard 20 to 80 scale, where higher scores indicate greater anxiety and a transformed score of 40 or higher denotes clinically significant anxiety.
Reported as the mean transformed score and the proportion of participants exceeding the cutoff.
The association between STAI-6 score and intraoperative sensory outcomes (the binary primary outcome, VAS intensity, and timepoint-specific incidence of sensation) is estimated within each participating center by multivariable regression adjusted for dermatomal level and number of previous cesarean deliveries, with site-specific estimates pooled by a DerSimonian-Laird random-effects model (adjusted odds ratios or beta coefficients, 95% CI).
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STAI-6 measured at preoperative baseline (day of surgery); intraoperative sensory outcomes assessed across the six surgical timepoints during the cesarean delivery (up to a maximum of 1 day)
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Proportion of Participants Who Indicated They Would Have Preferred General Anesthesia for Any Part of the Surgery
Prazo: Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins)
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At the conclusion of surgery, all participants (regardless of whether they requested any intraoperative intervention) are asked a single standardized yes/no question: "Overall, would you have preferred to receive general anesthesia (i.e., be asleep) for any part of this surgery?"
The outcome is the proportion (percentage) of participants answering yes.
This captures the full spectrum of intraoperative experience, including participants who found their experience distressing without requesting treatment during surgery.
Site-specific proportions are estimated with 95% Clopper-Pearson exact confidence intervals and pooled across participating centers using a DerSimonian-Laird random-effects model.
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Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins)
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Total Supplemental Intraoperative Intravenous Analgesia Administered, by Drug Type and Cumulative Dose
Prazo: Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins)
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The total supplemental intravenous analgesia administered by the clinical team during surgery is recorded by drug type and cumulative dose (including agents such as fentanyl, ketamine, and dexmedetomidine).
The outcome reports, for each drug, the proportion of participants who received it and the cumulative dose administered (summarized as median with interquartile range or mean with standard deviation, as appropriate to the distribution).
All administration decisions rest with the treating clinician; the research team records only what was given.
Site-specific summaries are pooled across participating centers using a DerSimonian-Laird random-effects model.
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Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins)
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In-Hospital Opioid Consumption From End of Surgery to Discharge, in Oral Morphine Milligram Equivalents (MME)
Prazo: From end of surgery to hospital discharge (up to a maximum of 7 days)
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Total opioid consumption from the end of surgery to hospital discharge is recorded (including agents such as fentanyl, hydromorphone, and morphine) and converted to a common unit of oral morphine milligram equivalents (MME).
The outcome is the cumulative MME per participant, summarized within each participating center as median with interquartile range or mean with standard deviation, as appropriate to the distribution, and pooled across participating centers using a DerSimonian-Laird random-effects model.
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From end of surgery to hospital discharge (up to a maximum of 7 days)
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Length of Hospital Stay From End of Surgery to Discharge
Prazo: From end of surgery to official hospital discharge (up to a maximum of 7 days)
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Length of hospital stay is defined as the total duration, in hours, from the end of surgery to official hospital discharge.
The outcome is summarized within each participating center as median with interquartile range or mean with standard deviation, as appropriate to the distribution, and pooled across participating centers using a DerSimonian-Laird random-effects model.
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From end of surgery to official hospital discharge (up to a maximum of 7 days)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Juliana Kruthof, MD, MSc, FRCPC, Department of Anesthesia BC Women's Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- Jagodnik KM, Ein-Dor T, Chan SJ, Titelman Ashkenazy A, Bartal A, Barry RL, Dekel S. Screening for post-traumatic stress disorder following childbirth using the Peritraumatic Distress Inventory. J Affect Disord. 2024 Mar 1;348:17-25. doi: 10.1016/j.jad.2023.12.010. Epub 2023 Dec 7.
- Saulnier L, Chau A, Barrera J, Massey S. Influence of Planned Versus Unplanned Cesarean Delivery on Postpartum Peritraumatic Distress: A Prospective Observational Study. J Obstet Gynaecol Can. 2025 Nov;47(11):103114. doi: 10.1016/j.jogc.2025.103114. Epub 2025 Sep 10.
- Stanford SER. What is 'genuine' failure of neuraxial anaesthesia? Anaesthesia. 2022 May;77(5):523-526. doi: 10.1111/anae.15723. Epub 2022 Mar 25. No abstract available.
- Mehdiratta JE, Saab R, Chen Z, Li YJ, Habib AS. Patient and procedural risk factors for increased postoperative pain after cesarean delivery under neuraxial anesthesia: a retrospective study. Int J Obstet Anesth. 2020 Nov;44:60-67. doi: 10.1016/j.ijoa.2020.07.006. Epub 2020 Jul 21.
- Plaat F, Stanford SER, Lucas DN, Andrade J, Careless J, Russell R, Bishop D, Lo Q, Bogod D. Prevention and management of intra-operative pain during caesarean section under neuraxial anaesthesia: a technical and interpersonal approach. Anaesthesia. 2022 May;77(5):588-597. doi: 10.1111/anae.15717. Epub 2022 Mar 24.
- Stanford SE, Bogod DG. Failure of communication: a patient's story. Int J Obstet Anesth. 2016 Dec;28:70-75. doi: 10.1016/j.ijoa.2016.08.001. Epub 2016 Aug 23.
- Lopez U, Meyer M, Loures V, Iselin-Chaves I, Epiney M, Kern C, Haller G. Post-traumatic stress disorder in parturients delivering by caesarean section and the implication of anaesthesia: a prospective cohort study. Health Qual Life Outcomes. 2017 Jun 2;15(1):118. doi: 10.1186/s12955-017-0692-y.
- Landau R, Richebe P. Tailoring postoperative pain management with a procedure-specific approach: how to best apply this concept to caesarean deliveries. Anaesthesia. 2021 May;76(5):587-589. doi: 10.1111/anae.15251. Epub 2020 Oct 14. No abstract available.
- Charles EA, Carter H, Stanford S, Blake L, Eley V, Carvalho B, Sultan P, Kua J, O'Carroll JE. Intraoperative Pain during Cesarean Delivery under Neuraxial Anesthesia: A Systematic Review and Meta-analysis. Anesthesiology. 2025 Jul 1;143(1):156-167. doi: 10.1097/ALN.0000000000005486. Epub 2025 Apr 4.
- Frank E, Sharpe EE, Kohn G, Kohl-Thomas B, Shaver C, Hofkamp MP. Predictors of intraoperative pain during cesarean delivery under regional anesthesia. Proc (Bayl Univ Med Cent). 2022 Jun 14;35(5):595-598. doi: 10.1080/08998280.2022.2086789. eCollection 2022.
- Sanchez J, Prabhu R, Guglielminotti J, Landau R. Pain during cesarean delivery: A patient-related prospective observational study assessing the incidence and risk factors for intraoperative pain and intravenous medication administration. Anaesth Crit Care Pain Med. 2024 Feb;43(1):101310. doi: 10.1016/j.accpm.2023.101310. Epub 2023 Oct 20.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
20 de julho de 2026
Conclusão Primária (Estimado)
Conclusão Primária
30 de maio de 2027
Conclusão do estudo (Estimado)
Conclusão do estudo
30 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
5 de janeiro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de janeiro de 2026
Primeira postagem (Real)
Primeira postagem
14 de janeiro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
3 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2026
Última verificação
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
Outros números de identificação do estudo
- H25-02656
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared.
Aggregated and summary-level results will be made available through peer-reviewed publications and conference presentations, but individual-level data will not be released.
This decision reflects the sensitive nature of the data collected, which include individual psychological assessments (post-traumatic stress, depression, and peritraumatic distress) and verbatim free-text descriptions of intraoperative experiences that carry a risk of participant re-identification, as well as the terms of participant consent and the Research Ethics Board approvals governing the study.
Requests for additional aggregated analyses may be directed to the principal investigator and will be considered subject to Research Ethics Board approval.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .