Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia (NCT07291388) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
44 participantsStarted 2025-12
Plain-language summary
This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia.
The participants will:
* Be randomly assigned in a 1:1 ratio to receive either a retrolaminar block with 0.25% bupivacaine plus epinephrine or a sham block (normal saline) prior to surgical incision.
* Receive standardized multimodal analgesia.
* Have follow-up by the Acute Pain Unit during the first 3 days, to assess opioid consumption (morphine) in 24 hours, pain intensity measured by Numeric Rating Scale, quality of recovery assessed by the QoR-15 questionnaire, intraoperative blood loss, and postoperative complications.
Who can participate
Age range
18 Years – 75 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:
* Adults aged 18-75 years, scheduled for lumbar spine fusion surgery by a trauma team
* American Society of Anesthesiologists (ASA) Classification I-III
* Willing and able to provide written informed consent to participate in the study.
Exclusion Criteria:
* History of chronic use of strong or weak opioids for more than 3 months.
* Diagnosis of chronic pain and treatment by a pain management team.
* ASA score greater than or equal to 4.
* Patients with prior lumbar spine surgery. Spinal instrumentation at the surgical site.
* Estimated creatinine clearance less than 60 ml/min.
* Coagulation disorder or abnormal coagulation tests.
* Infection at the surgical site.
* Weight less than 50 kg.
* Altered mental status that prevents reliable evaluation.
* Allergy to local anesthetics or analgesic drugs used in the study.
* Patients with contraindications to peripheral nerve blocks.
* Lumbar spine fixation due to oncologic disease or acute trauma.
* Use of intraoperative neuromonitoring and TIVA.
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.
What they're measuring
1
Opioid consumption during the first 24 hours postoperative
Timeframe: Daily consumption during the first 24 hours