NCT07768241

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Sep 2026Jul 2027

First Submitted

Initial submission to the registry

July 18, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

July 18, 2026

Last Update Submit

August 13, 2026

Conditions

Keywords

Psoas Muscle IndexMultifidus Muscle AreaParaspinal Muscle MorphologyQuality of Recovery-15Lumbar Magnetic Resonance ImagingLumbar Spine SurgeryPatient-Reported OutcomePostoperative Pain

Outcome Measures

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.

    Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery

Secondary Outcomes (6)

  • QoR-15 Scores at 48 Hours and 7 Days After Surgery

    48 hours and 7 days after surgery

  • Postoperative Numeric Rating Scale Pain Scores at Rest

    2, 6, 12, and 24 hours after surgery

  • Total Opioid Consumption During the First 24 Hours

    Within the first 24 hours after surgery

  • Requirement for Rescue Analgesia

    Within the first 24 hours after surgery

  • Incidence of Postoperative Nausea and Vomiting

    Within the first 24 hours after surgery

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Preoperative Psoas and Multifidus Muscle Measurements

Interventions

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

Elective Lumbar Disc Herniation Surgery Cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementPain, Postoperative

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Doğa Meriç Yükselen, MD

CONTACT

cansu ofluoğlu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

July 18, 2026

First Posted

August 17, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

August 17, 2026

Record last verified: 2026-08

Locations