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NCT07291388
Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
Conditions: Acute Pain, Anesthesia, Lumbar Spine Disease
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 44
Sponsor: Pontificia Universidad Catolica de Chile
Location: Hospital Clínico Pontificia Universidad Católica de Chile Santiago Santiago Metropolitan
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07291388). StuddyBuddy aggregates publicly available trial information.