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Not Yet RecruitingNCT07291388

Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia

Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
44 (estimated)
Sponsor
Pontificia Universidad Catolica de Chile · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed description

After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, the investigators will recruit patients who meet the inclusion criteria and provide written consent.

Conditions

Interventions

TypeNameDescription
PROCEDUREretrolaminar blockRetrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.
PROCEDURESham blockSham block in the retrolaminar area with saline solution on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.

Timeline

Start date
2025-12-01
Primary completion
2026-12-01
Completion
2027-03-01
First posted
2025-12-18
Last updated
2025-12-18

Source: ClinicalTrials.gov record NCT07291388. Inclusion in this directory is not an endorsement.

Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia (NCT07291388) · Clinical Trials Directory