- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07768241
Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery
Association of Preoperative Psoas Muscle Index and Multifidus Muscle Area With Postoperative Quality of Recovery Assessed Using the Quality of Recovery-15 (QoR-15) in Patients Undergoing Surgery for Lumbar Disc Herniation: A Prospective Observational Study
Recovery after surgery for a herniated disc in the lower back differs from person to person. The size of the muscles around the lower spine may be related to recovery, but this relationship is not well understood.
The purpose of this observational study is to determine whether the size of two lower-back muscles, the psoas and multifidus muscles, measured on magnetic resonance imaging (MRI) scans obtained before surgery is related to recovery after surgery. The study will include 100 adults aged 18 to 75 years who are scheduled for elective surgery for lumbar disc herniation.
Participants will receive their usual anesthesia, surgery, and postoperative care. The study will not require any additional imaging, blood tests, medicines, or procedures. Researchers will use each participant's existing preoperative lumbar MRI scan to measure the psoas and multifidus muscles. Participants will complete the 15-item Quality of Recovery questionnaire (QoR-15) before surgery and again 24 hours, 48 hours, and 7 days after surgery. Researchers will also collect information routinely recorded during care, including pain scores, pain medicine use, nausea and vomiting, time spent in the recovery unit, time to first walking, and length of hospital stay.
The primary objective is to determine whether preoperative psoas muscle index and multifidus muscle cross-sectional area are independently associated with postoperative Quality of Recovery-15 (QoR-15) scores 24 hours after lumbar disc herniation surgery.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a single-center, prospective observational cohort study involving 100 adults undergoing elective surgery for lumbar disc herniation. No treatment, exposure, or anesthetic technique will be assigned by the study protocol. All participants will receive standard general anesthesia, surgery, and postoperative care according to routine clinical practice and the decisions of the responsible clinical teams. No additional imaging, laboratory testing, medication, or invasive procedure will be performed for research purposes.
Existing preoperative lumbar magnetic resonance imaging scans obtained as part of routine clinical care will be evaluated. Muscle measurements will be performed on axial T2-weighted images at the level of the inferior endplate of the L3 vertebra. The right and left psoas muscles will be manually outlined, and their cross-sectional areas will be summed to calculate the total psoas area. The total psoas area will be divided by height squared to calculate the psoas muscle index in cm²/m².
The right and left multifidus muscles will be evaluated on the same MRI section. Their cross-sectional areas will be measured and summed to calculate the total multifidus muscle area. A height-adjusted multifidus muscle index will also be calculated. MRI measurements will be performed by an investigator who is unaware of the participants' clinical outcomes and QoR-15 scores.
Quality of recovery will be assessed using the validated Turkish version of the 15-item Quality of Recovery questionnaire. The QoR-15 evaluates physical comfort, emotional state, physical independence, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better recovery. The questionnaire will be administered before surgery and at 24 hours, 48 hours, and 7 days after surgery.
Postoperative pain at rest will be assessed using the Numeric Rating Scale at 2, 6, 12, and 24 hours after surgery. Other routinely collected data will include opioid and other analgesic consumption during the first 24 hours, requirement for rescue analgesia, postoperative nausea and vomiting, antiemetic requirement, length of stay in the post-anesthesia care unit, time to first mobilization, and total length of hospital stay.
The primary analysis will evaluate the associations of the preoperative psoas muscle index and multifidus muscle measurements with the QoR-15 score 24 hours after surgery. Secondary analyses will evaluate their associations with QoR-15 scores at 48 hours and 7 days, postoperative pain scores, analgesic consumption, postoperative nausea and vomiting, recovery unit stay, time to first mobilization, and hospital length of stay.
Correlations will be assessed using Pearson or Spearman correlation analysis, as appropriate. Multivariable linear regression analysis will be used to identify whether the preoperative muscle measurements are independently associated with the 24-hour QoR-15 score after adjustment for relevant demographic and clinical variables.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: cansu ofluoğlu, MD
- Número de telefone: +905358640564
- E-mail: cansuakin.iu@gmail.com
Estude backup de contato
- Nome: doğa meriç Yükselen, MD
- Número de telefone: +905362963155
- E-mail: d.m.boybeyi@gmail.com
Locais de estudo
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Istanbul, Turquia (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Contato:
- doğa meriç Yükselen, MD
- Número de telefone: +905362963155
- E-mail: d.m.boybeyi@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age between 18 and 75 years
- Scheduled for elective surgery for lumbar disc herniation
- American Society of Anesthesiologists physical status I-III
- Availability of a preoperative lumbar MRI obtained as part of routine clinical care
- Scheduled to undergo surgery under general anesthesia
- Sufficient cognitive and communication ability to understand and complete the quality of recovery (QoR-15) questionnaire
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- Emergency surgery
- Revision lumbar spine surgery
- Surgery for a spinal tumor, infection, trauma, vertebral fracture, spinal deformity, advanced spinal stenosis, or another condition other than lumbar disc herniation
- Planned spinal fusion or instrumentation
- History of a neuromuscular disorder
- Severe cognitive impairment, inability to communicate, or inability to complete the QoR-15 questionnaire
- Chronic opioid use or a history of opioid dependence
- Preoperative lumbar MRI images of insufficient quality for psoas or multifidus muscle measurement
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Elective Lumbar Disc Herniation Surgery Cohort
Adults aged 18 to 75 years with ASA physical status I-III who are scheduled for elective surgery for lumbar disc herniation under general anesthesia.
Participants will receive routine perioperative care, and no intervention will be assigned by the study protocol.
The exposures of interest are the preoperative psoas muscle index and multifidus muscle area and index measured using existing lumbar Magnetic Resonance Imaging (MRI) scans.
QoR-15 scores will be recorded before surgery and at 24 hours, 48 hours, and 7 days after surgery.
Postoperative pain, analgesic consumption, nausea and vomiting, recovery unit stay, time to first mobilization, and hospital stay will also be recorded.
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Preoperative psoas muscle index and multifidus muscle cross-sectional area and index will be measured by manual segmentation of existing axial T2-weighted lumbar MRI images at the L3 inferior endplate level.
No additional MRI examination or clinical intervention will be performed.
These measurements represent observational exposures whose associations with postoperative QoR-15 scores and other recovery outcomes will be evaluated
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of Recovery-15 (QoR-15) Total Score
Prazo: Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery
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The association between preoperative psoas muscle index and multifidus muscle measurements and the total Quality of Recovery-15 (QoR-15) score 24 hours after surgery will be evaluated using correlation and multivariable linear regression analyses.
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Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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QoR-15 Scores at 48 Hours and 7 Days After Surgery
Prazo: 48 hours and 7 days after surgery
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Quality of recovery will be assessed using the total Quality of Recovery-15 (QoR-15) score.
The questionnaire contains 15 items and has a total score ranging from 0 to 150, with higher scores indicating better postoperative recovery.
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48 hours and 7 days after surgery
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Postoperative Numeric Rating Scale Pain Scores at Rest
Prazo: 2, 6, 12, and 24 hours after surgery
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Pain intensity at rest will be assessed using the Numeric Rating Scale.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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2, 6, 12, and 24 hours after surgery
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Total Opioid Consumption During the First 24 Hours
Prazo: Within the first 24 hours after surgery
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The cumulative dose of opioid analgesics administered during the first 24 hours after surgery will be obtained from medication records.
If more than one opioid is administered, doses will be converted to intravenous morphine milligram equivalents for analysis.
Higher values indicate greater opioid consumption.
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Within the first 24 hours after surgery
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Requirement for Rescue Analgesia
Prazo: Within the first 24 hours after surgery
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The number and percentage of participants who require any additional rescue analgesic medication because of inadequate pain control will be recorded.
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Within the first 24 hours after surgery
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Incidence of Postoperative Nausea and Vomiting
Prazo: Within the first 24 hours after surgery
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The number and percentage of participants experiencing at least one episode of nausea, vomiting, or both will be recorded using patient reports and routine clinical records.
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Within the first 24 hours after surgery
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Length of Stay in the Post-Anesthesia Care Unit
Prazo: From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery
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Time from admission to discharge from the post-anesthesia care unit will be recorded in minutes.
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From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças ósseas
- Doenças musculoesqueléticas
- Complicações pós-operatórias
- Processos Patológicos
- Condições Patológicas, Anatômicas
- Doenças da coluna vertebral
- Hérnia
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Pós-operatório
- Deslocamento do Disco Intervertebral
Outros números de identificação do estudo
- FSMTRHPSOAS
- 2026/06-37 (Outro identificador: University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research Ethics Committee)
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