Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFatih Sultan Mehmet Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will consist of a consecutive sample of adult patients aged 18 to 75 years with ASA physical status I-III who are scheduled for elective surgery for lumbar disc herniation under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital. Eligible participants must have an existing preoperative lumbar MRI suitable for psoas and multifidus muscle measurements and must be able to complete the Turkish version of the QoR-15 questionnaire.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Preoperative Psoas and Multifidus Muscle Measurements
Other interventionPreoperative 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Elective Lumbar Disc Herniation Surgery Cohort1 intervention
Trial outcomes
Primary outcomes
1
Quality of Recovery-15 (QoR-15) Total Score
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
Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgerySecondary outcomes
1
QoR-15 Scores at 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
48 hours and 7 days after surgery2
Postoperative Numeric Rating Scale Pain Scores at Rest
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
2, 6, 12, and 24 hours after surgery3
Total Opioid Consumption During the First 24 Hours
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 surgery4
Requirement for Rescue Analgesia
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 surgerySponsors and contacts
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Source ClinicalTrials.gov
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