Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
Recruiting now
Conditions studied: Lumbar Spinal Stenosis, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis, Lumbar Disc Degeneration
In brief
This prospective, observational, non-randomized clinical study aims to evaluate the intraoperative and postoperative effects of opioid-free multimodal anesthesia compared with opioid-containing anesthesia methods in adult patients undergoing lumbar spinal surgery. Patients will be managed according to routine clinical practice and assigned to one of three groups based on the analgesic strategy used by the attending anesthesiologist: (1) opioid-free anesthesia using multimodal agents and/or erector spinae plane (ESP) block; (2) ESP block plus intraoperative opioids; or (3) opioid-based anesthesia without regional blocks. The primary objective is to compare postoperative pain control and opioid requirements within the first 48 hours after surgery. Secondary objectives include evaluating opioid-related side effects such as nausea, vomiting, pruritus, constipation, delayed mobilization, urinary retention, and postoperative complications classified according to the Clavien-Dindo system. Standard postoperative analgesia, including intravenous morphine patient-controlled analgesia (PCA), acetaminophen, and NSAIDs, will be provided for all patients. The study aims to determine whether an opioid-free multimodal analgesic approach can reduce opioid consumption and related adverse effects while maintaining adequate analgesia in patients undergoing lumbar spinal surgery.
Key facts
- Study ID
- NCT07489001
- Run by
- Marmara University
- People needed
- 75
- Starts
- 2025-12-09
- Expected to finish
- 2026-12-10
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Marmara university hospital — Istanbul, Maltepe, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.