Opioid-free versus opioid-based anesthesia for elective lumbar spine surgery
Prospective Comparative Evaluation of Intra-operative and Postoperative Outcomes Associated With Opioid Free Versus Opioid Based Anesthesia Techniques in Patients Undergoing Elective Lumbar Spinal Surgery
Marmara University · NCT07489001
This test compares opioid-free multimodal anesthesia (with or without an erector spinae plane block) against opioid-containing anesthesia in adults having elective lumbar spine surgery to see which controls pain better and reduces opioid need in the first 48 hours after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Marmara University (other) |
| Locations | 1 site (Istanbul, Maltepe) |
| Trial ID | NCT07489001 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, non-randomized comparison of three anesthetic approaches used in routine care for adult elective lumbar spine surgery. Patients are assigned to one of three groups based on the attending anesthesiologist's choice: opioid-free multimodal anesthesia (±ESP block), ESP block plus intraoperative opioids, or opioid-based anesthesia without regional blocks. Primary outcomes are postoperative pain scores and opioid consumption in the first 48 hours; secondary outcomes include opioid-related side effects and postoperative complications classified by Clavien-Dindo. Perioperative monitoring such as BIS and ANI are recorded, and standard inclusion/exclusion criteria apply.
Who should consider this trial
Good fit: Adults aged 18–75 scheduled for elective lumbar spinal surgery (stenosis, disc herniation, degenerative spondylolisthesis) with ASA I–III, no prior lumbar surgery, and able to consent and comply with postoperative pain assessments.
Not a fit: Patients with chronic pain syndromes, chronic opioid or gabapentinoid use, significant cardiac or renal disease, BMI >40, pregnancy, or other major exclusion criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower postoperative opioid use and reduce opioid-related side effects while maintaining good pain control after lumbar spine surgery.
How similar studies have performed: Prior small trials and case series have suggested opioid-sparing and ESP block strategies can reduce opioid consumption and side effects, but high-quality randomized evidence in lumbar spine surgery remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 75 years * Elective surgery only * Scheduled for elective lumbar spinal surgery (lumbar spinal stenosis and/or lumbar disc herniation) * ASA physical status I-III * No previous lumbar spine surgery * Able to provide written informed consent * BIS monitoring available and recorded * Ability to comply with postoperative pain assessment (NRS/VAS) * Stable hemodynamic status preoperatively Exclusion Criteria: * Age younger than 18 or older than 75 * Inability or unwillingness to provide informed consent * Severe psychiatric disease or cognitive impairment * Emergency surgery cases * BMI \> 40 kg/m² * Pregnancy * Uncontrolled hypertension, arrhythmia, or severe cardiac disease * Renal failure * Chronic beta-blocker use * Coagulation disorders * Chronic alcohol dependence or substance use * Neurological deficits affecting perception of pain * Chronic pain syndrome (fibromyalgia, chronic LBP \> 3 months) * Chronic gabapentinoid use * Anemia * Known allergy to any anesthetic or analgesic agents used in the study * Local infection at the intended ESP block injection site * Intraoperative change in anesthetic technique that deviates from initial planned management * Pediatric patients (\<18 years)
Where this trial is running
Istanbul, Maltepe
- Marmara university hospital — Istanbul, Maltepe, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: burcu Akyüz irfanoğlu, MD — marmara university hospital
- Study coordinator: Burcu Akyüz Irfanoğlu, MD
- Email: brcakyz1@gmail.com
- Phone: 900-555-725-9649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spinal Stenosis, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis, Lumbar Disc Degeneration, Opioid-Free Anesthesia, Multimodal Analgesia, Erector Spinae Plane Block, ESP Block