- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: cansu ofluoğlu, MD
- Número de teléfono: +905358640564
- Correo electrónico: cansuakin.iu@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: doğa meriç Yükselen, MD
- Número de teléfono: +905362963155
- Correo electrónico: d.m.boybeyi@gmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Contacto:
- doğa meriç Yükselen, MD
- Número de teléfono: +905362963155
- Correo electrónico: d.m.boybeyi@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Recovery-15 (QoR-15) Total Score
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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QoR-15 Scores at 48 Hours and 7 Days After Surgery
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Anatómicas
- Enfermedades de la columna
- Hernia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Desplazamiento del disco intervertebral
Otros números de identificación del estudio
- FSMTRHPSOAS
- 2026/06-37 (Otro identificador: University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research Ethics Committee)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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