Retrolaminar Analgesia for LuMbar Surgery (NCT07334288) | Clinical Trial Compass
RecruitingNot Applicable
Retrolaminar Analgesia for LuMbar Surgery
Chile50 participantsStarted 2026-03-01
Plain-language 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
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.