Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752, Turkey (Türkiye)
NCT Number: NCT07768241
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Istanbul, 34752, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery
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.
Time frame: 48 hours and 7 days after surgery
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.
Time frame: 2, 6, 12, and 24 hours after surgery
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.
Time frame: Within the first 24 hours after surgery
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.
Time frame: Within the first 24 hours after surgery
The number and percentage of participants who require any additional rescue analgesic medication because of inadequate pain control will be recorded.
Time frame: Within the first 24 hours after surgery
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.
Time frame: From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery
Time from admission to discharge from the post-anesthesia care unit will be recorded in minutes.
Contact information is provided by the study sponsor or research team.
Doğa Meriç Yükselen, MD
CONTACT
cansu ofluoğlu, MD
CONTACT
Fatih Sultan Mehmet Training and Research Hospital
Other
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
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