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Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery

13 giugno 2026 aggiornato da: Zhang Ni, Tongji Hospital

Perioperative Pain Phenotyping and Incision Pain Mapping Using Quantitative Sensory Testing in Patients Undergoing Thoracoscopic or Robotic-assisted Lung Resection: A Prospective Observational Pilot Cohort Study

Postoperative pain remains a common and clinically important burden after thoracic surgery and may progress to chronic postsurgical pain. Conventional pain assessment mainly relies on patient-reported pain intensity and analgesic consumption, which may not fully capture peri-incisional sensory abnormalities, mechanical hyperalgesia, or central sensitization.

This prospective observational pilot cohort study aims to evaluate the feasibility and acceptability of perioperative quantitative sensory testing (QST) and incision pain mapping in adult patients undergoing elective thoracoscopic or robotic-assisted lung resection. Participants will undergo baseline assessment before surgery, serial postoperative pain assessments during the first 72 hours, QST and mechanical hyperalgesia pain mapping at 48-72 hours after surgery, and follow-up assessments at discharge, 1 month, and 3 months after surgery.

The primary feasibility outcomes include recruitment rate, QST completion rates, follow-up completion rates, QST-related discontinuation rate, study-related adverse events, and data completeness. The main clinical mechanistic outcome is the area of peri-incisional mechanical hyperalgesia at 48-72 hours after surgery. Secondary outcomes include acute postoperative pain intensity, pain burden over 72 hours, opioid consumption, quality of recovery, QST changes, pain-map characteristics, and chronic postsurgical pain at 3 months.

This study will not assign or modify therapeutic interventions. All anesthetic, surgical, and analgesic management will be determined by the routine clinical care team. The study is expected to provide feasibility data, preliminary effect estimates, and mechanistic information for future larger perioperative pain studies.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a single-center, prospective, observational pilot cohort study conducted in adult patients scheduled to undergo elective thoracoscopic or robotic-assisted lung resection. The study is designed to characterize perioperative pain phenotypes using standardized quantitative sensory testing (QST), incision-centered mechanical hyperalgesia pain mapping, serial pain intensity assessments, analgesic exposure, psychological and sleep-related questionnaires, and exploratory inflammatory or plasma biomarker measurements.

Eligible participants will provide written informed consent before surgery. Baseline assessments will be performed 1-3 days before surgery and will include demographic and clinical data collection, baseline pain history, psychological and sleep-related questionnaires, preoperative QST, and blood sampling. QST will assess sensory function in the surgical-side thoracic region, contralateral mirror region, and a remote control site where applicable.

During the first 72 hours after surgery, resting and movement-related numeric rating scale pain scores will be collected at prespecified time points, together with perioperative anesthetic, regional block, surgical, analgesic, and recovery-related information. Opioid consumption will be converted to morphine milligram equivalents.

At 48-72 hours after surgery, participants will undergo core postoperative QST and incision-centered mechanical pain mapping. The pain map will be generated around the incision or main port site in eight radial directions. Standardized mechanical stimulation will be applied from normal surrounding skin toward the incision, and boundary points will be marked when the participant reports a transition from normal sensation to increased pain, sharpness, burning, or abnormal discomfort. These boundary points will be connected to estimate the area of mechanical hyperalgesia.

Additional assessments will be performed before discharge, at 1 month, and at 90 ± 14 days after surgery. Follow-up assessments will evaluate persistent pain, pain intensity, pain interference, neuropathic pain features, QST changes, pain-map characteristics, quality of recovery, and exploratory blood biomarkers. Chronic postsurgical pain will be assessed at 3 months after surgery and defined as new or worsened pain related to the surgical area, persisting for at least 3 months after surgery, and not better explained by other causes.

The study will not assign any therapeutic intervention. Surgical technique, anesthetic management, regional analgesia, postoperative analgesia, chest tube management, and perioperative care will follow routine clinical practice. Key perioperative variables will be prospectively collected and considered as potential confounders in statistical analyses.

Tipo di studio

Osservativo

Iscrizione (Stimato)

46

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Hubei
      • Wuhan, Hubei, Cina, 430030

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients scheduled to undergo elective thoracoscopic or robotic-assisted lung resection at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Descrizione

Inclusion Criteria:

  1. Male
  2. Scheduled to undergo elective thoracoscopic or robotic-assisted lung resection.
  3. American Society of Anesthesiologists physical status I to III.
  4. Able to understand and communicate adequately and to complete study questionnaires independently or with assistance from study staff.
  5. Willing to undergo QST assessment, perioperative venous blood sampling, and postoperative follow-up.
  6. Able and willing to provide written informed consent.

Exclusion Criteria:

  1. Definite chronic chest wall, shoulder, back, or upper limb pain with an average 2. Numeric Rating Scale score of 3 or higher during the preceding week.

3. Definite painful neuropathic disease or long-term use of opioids or other analgesics for more than 2 weeks.

4. Peripheral neuropathy, spinal cord disease, or other neurological disease that may substantially interfere with interpretation of QST results.

5. Severe cognitive impairment, psychiatric disorder, communication disorder, or inability to complete questionnaires and QST assessments.

6. Active infection, active autoimmune disease, or other disease condition that may substantially affect inflammatory protein measurements.

7. Emergency surgery, conversion to open thoracotomy, extensive chest wall resection, or severe intraoperative complications.

8. Any condition that, in the opinion of the investigator, makes the participant unsuitable for continued participation in the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Elective Thoracoscopic or Robotic-assisted Lung Resection Cohort
Adult patients scheduled for elective thoracoscopic or robotic-assisted lung resection will be enrolled and followed prospectively from the preoperative period to 3 months after surgery. Participants will undergo observational assessments including questionnaires, quantitative sensory testing, peri-incisional mechanical hyperalgesia pain mapping, serial postoperative pain assessments, analgesic exposure recording, and exploratory blood sampling. No therapeutic intervention will be assigned by the investigators.
Altro: Perioperative QST and incision pain mapping assessment
Participants will undergo non-invasive perioperative quantitative sensory testing and incision-centered mechanical pain mapping at prespecified time points. These assessments are observational and will not determine or modify clinical anesthesia, analgesia, or surgical management.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Rate
Lasso di tempo: Baseline
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
Baseline
Completion Rate of Baseline Quantitative Sensory Testing
Lasso di tempo: Preoperative period, 1 to 3 days before surgery
Proportion of enrolled participants who complete the planned baseline QST assessment before surgery.
Preoperative period, 1 to 3 days before surgery
Completion Rate of Postoperative QST and Incision Pain Mapping
Lasso di tempo: 48 to 72 hours after surgery
Proportion of enrolled participants who complete the core postoperative QST assessment and incision-centered mechanical hyperalgesia pain mapping.
48 to 72 hours after surgery
Completion Rate of 1-month Follow-up
Lasso di tempo: 1 month after surgery
Proportion of enrolled participants who complete the planned 1-month postoperative follow-up assessment.
1 month after surgery
Completion Rate of 3-month Pain Outcome Follow-up
Lasso di tempo: 90 ± 14 days after surgery
Proportion of enrolled participants who complete the primary 3-month postoperative pain outcome assessment.
90 ± 14 days after surgery
QST-related Discontinuation Rate
Lasso di tempo: From baseline assessment to 3 months after surgery
Proportion of participants who discontinue QST or pain mapping prematurely because of pain intolerance, fatigue, anxiety, or other participant-related reasons.
From baseline assessment to 3 months after surgery
Study-related Adverse Event Rate
Lasso di tempo: From baseline assessment to 3 months after surgery
Proportion of participants with study-related adverse events, including marked discomfort, transient pain exacerbation, local discomfort related to QST or pain mapping, or adverse events related to blood sampling.
From baseline assessment to 3 months after surgery
Data Completeness of Key Study Variables
Lasso di tempo: From baseline assessment to 3 months after surgery
Proportion of missing data for key variables
From baseline assessment to 3 months after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Movement-related Pain Intensity During the First 72 Hours After Surgery
Lasso di tempo: 1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
Movement-related pain intensity measured using an 11-point Numeric Rating Scale during turning in bed or active mobilization, where 0 indicates no pain and 10 indicates the worst imaginable pain.
1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
Resting Pain Intensity During the First 72 Hours After Surgery
Lasso di tempo: 1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
Resting pain intensity measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
Area of Peri-incisional Mechanical Hyperalgesia
Lasso di tempo: 48 to 72 hours after surgery
Area of mechanical hyperalgesia around the surgical incision or main port site, measured in square centimeters using standardized incision-centered mechanical pain mapping.
48 to 72 hours after surgery
Area Under the Curve of Resting Pain Scores
Lasso di tempo: 0 to 72 hours after surgery
Cumulative resting pain burden calculated as the area under the curve of serial resting Numeric Rating Scale pain scores during the first 72 postoperative hours.
0 to 72 hours after surgery
Area Under the Curve of Movement-related Pain Scores
Lasso di tempo: 0 to 72 hours after surgery
Cumulative movement-related pain burden calculated as the area under the curve of serial movement-related Numeric Rating Scale pain scores during the first 72 postoperative hours
0 to 72 hours after surgery
Cumulative Opioid Consumption
Lasso di tempo: 0 to 72 hours after surgery
Total postoperative opioid consumption during the first 72 hours after surgery, converted to morphine milligram equivalents.
0 to 72 hours after surgery
Quality of Recovery-15 Score
Lasso di tempo: 72 hours after surgery and before discharge
Postoperative recovery quality assessed using the 15-item Quality of Recovery questionnaire. Higher scores indicate better recovery.
72 hours after surgery and before discharge
Analgesia-related Adverse Effects
Lasso di tempo: 0 to 72 hours after surgery
Incidence of analgesia-related adverse effects, including postoperative nausea and vomiting, excessive sedation, dizziness, or other analgesia-related symptoms.
0 to 72 hours after surgery
Time to First Ambulation
Lasso di tempo: Perioperative
Time from the end of surgery to the first documented postoperative ambulation.
Perioperative
Chest Tube Duration
Lasso di tempo: Perioperative
Duration of postoperative chest tube drainage, measured in hours or days.
Perioperative
Postoperative Length of Hospital Stay
Lasso di tempo: Perioperative
Number of days from surgery to hospital discharge.
Perioperative
Perioperative Complications
Lasso di tempo: Perioperative
Incidence of perioperative complications recorded during hospitalization
Perioperative
Change in Quantitative Sensory Testing Parameters
Lasso di tempo: Baseline, 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Changes in QST parameters measured at the surgical-side thoracic region, contralateral mirror region, and remote control site when applicable.
Baseline, 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Maximum Radius of Peri-incisional Pain Map
Lasso di tempo: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Maximum radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.
48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Minimum Radius of Peri-incisional Pain Map
Lasso di tempo: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Minimum radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.
48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Incidence of Persistent Pain at 1 Month
Lasso di tempo: 1 month after surgery
Proportion of participants reporting pain related to the surgical area at 1 month after surgery.
1 month after surgery
Incidence of Chronic Postsurgical Pain at 3 Months
Lasso di tempo: 90 ± 14 days after surgery
Proportion of participants with new or worsened pain related to the surgical area persisting at 3 months after surgery and not better explained by other causes.
90 ± 14 days after surgery
Pain Interference at 3 Months
Lasso di tempo: 90 ± 14 days after surgery
Pain-related interference with daily activity, sleep, and function assessed using the Brief Pain Inventory-short form.
90 ± 14 days after surgery
Neuropathic Pain Features at 3 Months
Lasso di tempo: 90 ± 14 days after surgery
Neuropathic pain symptoms, such as numbness, burning pain, electric shock-like pain, or touch-evoked pain, assessed using the DN4 questionnaire and symptom interview.
90 ± 14 days after surgery

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Psychological Factors and Postoperative Pain
Lasso di tempo: Baseline to 3 months after surgery
Association of baseline psychological factors
Baseline to 3 months after surgery
Blood-based Inflammatory or Plasma Biomarkers
Lasso di tempo: Baseline, 48 ± 12 hours after surgery, before discharge, 1 month, and 90 ± 14 days after surgery when feasible
Exploratory changes in inflammatory markers
Baseline, 48 ± 12 hours after surgery, before discharge, 1 month, and 90 ± 14 days after surgery when feasible

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tongji Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 giugno 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

28 febbraio 2027

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TJ-IRB202605020

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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