Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia (RBLUF)

December 5, 2025 updated by: Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Victor Contreras, MSN
  • Phone Number: 3414 56223543414
  • Email: vecontre@uc.cl

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retrolaminar block
Participants received retrolaminar block with 0.25% Bupivacaine (20 ml) plus epinephrine (5 mcg/ml), on both sides of the vertebral lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.
Procedure: retrolaminar block
Retrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.
Sham Comparator: Sham block
Participants received a retrolaminar sham block with 0.9% saline solution (20 ml), on both sides of the vertebra lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.
Procedure: Sham block
Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption during the first 24 hours postoperative
Time Frame: Daily consumption during the first 24 hours
To assess rescue opioid consumption, expressed as morphine equivalents, during the first 24 hours postoperative.
Daily consumption during the first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Numeric Rating Score (NRS) during the first 3 postoperative days
Time Frame: Daily NRS during the first 3 postoperative days
The NRS (Numeric Rating Scale) is commonly used to assess pain intensity. Its minimum score is 0, indicating no pain, and its maximum score is 10, indicating the worst pain imaginable. This scale is simple and allows patients to rate their pain using a number from 0 to 10. The objective is to assess the intensity of acute postoperative pain, expressed as NRS, during the first 3 postoperative days.
Daily NRS during the first 3 postoperative days
Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.
Time Frame: Preoperative score and daily score during the first 3 postoperative days
The QoR-15 is a validated instrument in the literature that assesses the quality of recovery in patients after surgery. It is a multidimensional measurement tool that allows healthcare professionals to gain an overview of the patient's well-being during the postoperative period. The questionnaire consists of 15 items, covering 5 dimensions: Physical Comfort, Physical Independence, Emotional Support, Psychological Well-being, and Satisfaction with Recovery. The minimum score on the scale is 0 points, and the maximum score is 150 points. This range is obtained by summing the scores of the different categories evaluated in the QoR-15 scale, where a higher score indicates a better quality of postoperative recovery.
Preoperative score and daily score during the first 3 postoperative days
bleeding and transfusions
Time Frame: Intraoperative and during the first 3 days
Subjective assessment of total intraoperative bleeding (mild, moderate, severe), blood in collectors, number of compresses with blood, hematocrit variations at 24 hours after the procedure and need for transfusion in the perioperative period.
Intraoperative and during the first 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241022008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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