Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07334288

Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial

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

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of ultrasound-guided retrolaminar nerve blocks added to standard multimodal pain management for patients undergoing lumbar spine surgery. This randomized controlled trial aims to reduce postoperative opioid use and improve pain control after surgery. The study includes adult patients scheduled for elective lumbar spine surgery with instrumentation and assesses various outcomes related to pain and recovery. Participants are randomly assigned to one of two groups: one group receives bilateral ultrasound-guided retrolaminar blocks with Bupivacaine and Epinephrine before surgery along with standard multimodal analgesia, while the other group receives only the standard multimodal analgesia without the regional block. Standard anesthesia medications include Propofol, Remifentanil, and Rocuronium. The retrolaminar block is performed by an experienced anesthesiologist using ultrasound guidance. During the study, researchers will monitor total opioid use in the first 24 hours after surgery, pain intensity at multiple time points up to 72 hours, time to first rescue analgesia, sensory block duration, and incidence of nausea or vomiting. Other assessments include hospital length of stay, patient satisfaction, sleep quality, time to ambulation, and chronic pain development up to 6 months. Participation involves use of a patient-controlled analgesia device and follow-up visits to evaluate recovery and long-term pain outcomes.

CONDITIONS

Brief 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 such as bupivacaine, levobupivacaine, or lidocaine
  • Contraindication to regional anesthesia like infection at injection site or coagulopathy
  • Chronic opioid use daily for more than 3 months before surgery
  • Severe psychiatric disorder preventing informed consent
  • Emergency surgery
  • Diabetes with preoperative glucose above 180 mg/dl
  • Pregnancy or breastfeeding
  • Body mass index (BMI) over 40 kg/m²
  • Reoperation or revision of previous spinal surgery at the same level

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day plus up to 72 hours postoperatively

Participants undergo lumbar spine surgery with standardized general anesthesia and multimodal analgesia. The experimental group additionally receives bilateral ultrasound-guided retrolaminar blocks before surgery to manage postoperative pain.

1 surgery visit and hospital stay with assessments up to 72 hours

Follow-up

Duration - Up to 6 months after surgery

Participants are monitored for recovery outcomes including pain levels, time to ambulation, adverse events, and development of chronic pain.

Follow-up visits at 3 and 6 months

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

N

Nicolás Valls, MD, PhD

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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Published Research Related To This Trial

Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures.

Hans J Gerbershagen, Sanjay Aduckathil, Albert J M van Wijck...

https://pubmed.ncbi.nlm.nih.gov/23392233