Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Acute Pain, Anesthesia, Lumbar Spine Disease
In brief
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.
Key facts
- Study ID
- NCT07291388
- Run by
- Pontificia Universidad Catolica de Chile
- People needed
- 44
- Starts
- 2026-06-30
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hospital Clínico Pontificia Universidad Católica de Chile — Santiago, Santiago Metropolitan, Chile (enrolling)
Full record on ClinicalTrials.gov
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