Postoperative RecoveryNCT07768241
Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery
An observational study of Postoperative Recovery and Lumbar Disc Herniation, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Recovery, Lumbar Disc Herniation
- What is being tested?
- Preoperative Psoas and Multifidus Muscle Measurements
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752
doğa meriç Yükselen, MD, +905362963155, d.m.boybeyi@gmail.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Postoperative Recovery, Lumbar Disc Herniation
- Being tested
- Preoperative Psoas and Multifidus Muscle Measurements
- Keywords
- Psoas Muscle Index, Multifidus Muscle Area, Paraspinal Muscle Morphology, Quality of Recovery-15, Lumbar Magnetic Resonance Imaging, Lumbar Spine Surgery, Patient-Reported Outcome, Postoperative Pain
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Psoas and Multifidus Muscle MeasurementsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Preoperative Psoas and Multifidus Muscle Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery
Secondary outcomes (6)
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.
Measured: 48 hours and 7 days after surgery
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.
Measured: 2, 6, 12, and 24 hours after surgery
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.
Measured: Within the first 24 hours after surgery
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.
Measured: Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
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.
Measured: Within the first 24 hours after surgery
Length of Stay in the Post-Anesthesia Care Unit
Time from admission to discharge from the post-anesthesia care unit will be recorded in minutes.
Measured: From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doğa Meriç Yükselen, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768241
- Sponsor's protocol ID
- FSMTRHPSOAS
- Other IDs
- 2026/06-37
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07768241
- Acronym / sponsor ID
- FSMTRHPSOAS
- Conditions
- Postoperative Recovery, Lumbar Disc Herniation
- Keywords
- Psoas Muscle Index, Multifidus Muscle Area, Paraspinal Muscle Morphology, Quality of Recovery-15, Lumbar Magnetic Resonance Imaging, Lumbar Spine Surgery, Patient-Reported Outcome, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Lumbar Disc Herniation Surgery Cohort | – | Other: Preoperative Psoas and Multifidus Muscle MeasurementsAdults 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Psoas and Multifidus Muscle MeasurementsPreoperative 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 | Other | Elective Lumbar Disc Herniation Surgery Cohort |
Primary outcome
Quality of Recovery-15 (QoR-15) Total Score
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.
6 secondary outcomes
QoR-15 Scores at 48 Hours and 7 Days After Surgery
Time frame: 48 hours and 7 days after surgery
Postoperative Numeric Rating Scale Pain Scores at Rest
Time frame: 2, 6, 12, and 24 hours after surgery
Total Opioid Consumption During the First 24 Hours
Time frame: Within the first 24 hours after surgery
Requirement for Rescue Analgesia
Time frame: Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: Within the first 24 hours after surgery
Length of Stay in the Post-Anesthesia Care Unit
Time frame: From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for Postoperative Recovery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Gynecologic Surgery, General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Recovery and Lumbar Disc Herniation, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doğa Meriç Yükselen, MD (+905362963155, d.m.boybeyi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) Total Score (time frame: Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.