Retrolaminar nerve block for lumbar surgery pain
Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial
NA · Universidad de los Andes, Chile · NCT07334288
This trial will test whether adding an ultrasound-guided retrolaminar nerve block to standard multimodal pain management reduces opioid use after elective lumbar spine surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universidad de los Andes, Chile (other) |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT07334288 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial at Clínica Universidad de Los Andes in Santiago will enroll 50 adults undergoing elective instrumented lumbar spine surgery and randomize them 1:1 to receive either bilateral ultrasound-guided retrolaminar blocks with ropivacaine plus standard multimodal analgesia or standard multimodal analgesia alone. All patients receive standardized general anesthesia and postoperative multimodal medications, and the retrolaminar block is performed at the end of surgery with 20 ml of 0.5% ropivacaine per side. The primary outcome is cumulative morphine consumption via PCA in the first 24 postoperative hours, and secondary outcomes include serial pain scores, time to first rescue analgesia, nausea/vomiting, length of stay, patient satisfaction, and chronic pain at 3 and 6 months. Variable block randomization will be used and the sample size of 50 provides 80% power to detect a clinically important opioid-sparing effect.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 scheduled for elective instrumented lumbar spine surgery who are ASA I–III, can use PCA, and are not chronic opioid users.
Not a fit: Patients with chronic opioid use, contraindications to regional anesthesia, major obesity (BMI >40), reoperations at the same level, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the technique could reduce immediate postoperative opioid requirements and improve pain control after lumbar surgery.
How similar studies have performed: Other small studies of regional blocks for spine surgery have reported opioid-sparing and pain benefits, but retrolaminar-block-specific evidence is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 index (BMI) \>40 kg/m² * Reoperation or revision of the same level of previous spinal surgery
Where this trial is running
Santiago, Santiago Metropolitan
- Clínica Universidad de los Andes, Chile — Santiago, Santiago Metropolitan, Chile (RECRUITING)
Study contacts
- Study coordinator: Roberto Coloma, MD
- Email: rcoloma@clinicauandes.cl
- Phone: (56) 22 618 3100
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: Postoperative Pain, Lumbar Surgery, Back Pain Lower Back Chronic, Opioid Analgesia, Regional Anaesthesia, retrolaminar block, regional anesthesia, lumbar spine surgery