Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07334288

Retrolaminar Analgesia for LuMbar Surgery

Led by Universidad de los Andes, Chile · Updated on 2026-04-13

50

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.

CONDITIONS

Official Title

Retrolaminar Analgesia for LuMbar Surgery

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18-80 years
  • Scheduled for elective lumbar spine surgery with instrumentation
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Willing and able to provide written informed consent
  • Able to use patient-controlled analgesia (PCA) device
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Known allergy to local anesthetics (bupivacaine, levobupivacaine, lidocaine) or any study medication
  • Contraindication to regional anesthesia such as infection at injection site or coagulopathy
  • Chronic opioid use daily for more than 3 months prior to surgery
  • Severe psychiatric disorder preventing informed consent
  • Emergency surgery
  • Diabetes mellitus with preoperative glucose over 180 mg/dl
  • Pregnancy or breastfeeding
  • Body mass index (BMI) over 40 kg/m²
  • Reoperation or revision of the same level of previous spinal surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clínica Universidad de los Andes, Chile

Santiago, Santiago Metropolitan, Chile, 171571

Actively Recruiting

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Research Team

R

Roberto Coloma, MD

CONTACT

N

Nicolás Valls, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Retrolaminar Analgesia for LuMbar Surgery | DecenTrialz