Retrolaminar Analgesia for LuMbar Surgery
This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combine
| Condition(s) | Postoperative Pain, Lumbar Surgery, Back Pain Lower Back Chronic, Opioid Analgesia, Regional Anaesthesia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up. |
| Who can participate | Inclusion Criteria: * Adult patients aged 18-80 years * Scheduled for elective lumbar spine surgery (with instrumentation) * American Society of Anesthesiologists (ASA) physical status I-III * Willing and able to provide written informed consent * Able to use patient-controlled analgesia (PCA) device Exclusion Criteria: * Refusal to participate in the study * Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication * Contraindication to regional anesthesia (infection at injection site, coagulopathy) * Chronic opioid use (daily use for \>3 months prior to surgery) * Severe psychiatric disorder that precludes informed consent * Emergency surgery * Diabetes mellitus with preoperative glucose \>180 mg/dl * Pregnancy or breastfeeding * Body mass ind |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Universidad de los Andes, Chile |
| Locations | Santiago, Santiago Metropolitan, Chile |
| Start date | 2026-03-01 |
| NCT ID | NCT07334288 |
| Official listing | https://clinicaltrials.gov/study/NCT07334288 |