Retrolaminar Analgesia for LuMbar Surgery

NCT07334288 | Recruiting

• 1 other identifier: CUA2025-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Opioid Analgesia; Postoperative Pain; Lumbar Surgery; Back Pain Lower Back Chronic; Regional Anaesthesia

Keywords

retrolaminar block; regional anesthesia; lumbar spine surgery; Multimodal analgesia; opioid consumption; Ultrasound-guided nerve block

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid consumption

  Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours

  First 24 hours after surgery

Secondary Outcomes (5)

• Pain Intensity

  Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours

• Duration of Sensory Block

  From block performance up to 72 hours

• Time to First Rescue Analgesia

  From end of surgery up to 24 hours

• Incidence of PONV

  First 24 hours postoperatively

• Length of hospital stay

  From admission to discharge, assessed up to 30 days

Other Outcomes (2)

• Patient satisfaction

  72 hours postoperatively

• Chronic Pain Development

  3 months and 6 months postoperatively

Study Arms (2)

Retrolaminar Block & Standard Analgesia

EXPERIMENTAL

Patients receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery, along with standard multimodal analgesia.

Procedure: Ultrasound-Guided Retrolaminar Block

Standard Analgesia Only

ACTIVE COMPARATOR

Patients receive standard multimodal analgesia without regional anesthesia block.

Other: Standard Analgesia

Interventions

Ultrasound-Guided Retrolaminar Block PROCEDURE

Patients will receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery. The block will be performed by an experienced anesthesiologist using real-time ultrasound guidance.

Retrolaminar Block & Standard Analgesia

Standard Analgesia OTHER

Patients receive standard multimodal analgesia without regional anesthesia block.

Standard Analgesia Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

Clínica Universidad de los Andes, Chile

Santiago, Santiago Metropolitan, 171571, Chile

RECRUITING

Related Publications (4)

• Zeballos JL, Voscopoulos C, Kapottos M, Janfaza D, Vlassakov K. Ultrasound-guided retrolaminar paravertebral block. Anaesthesia. 2013 Jun;68(6):649-51. doi: 10.1111/anae.12296. No abstract available.

  PMID: 23662765 BACKGROUND

• Ardon AE, Prasad A, McClain RL, Melton MS, Nielsen KC, Greengrass R. Regional Anesthesia for Ambulatory Anesthesiologists. Anesthesiol Clin. 2019 Jun;37(2):265-287. doi: 10.1016/j.anclin.2019.01.005. Epub 2019 Mar 15.

  PMID: 31047129 BACKGROUND

• Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.

  PMID: 21804697 BACKGROUND

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nicolas J Valls, M.D, Ph.D

  Anesthesiologyst, Clinica Universidad de los Andes

  STUDY DIRECTOR

Central Study Contacts

Roberto Coloma, MD

CONTACT

(56) 22 618 3100; rcoloma@clinicauandes.cl

Nicolás Valls, MD, PhD

CONTACT

+56 9 33741332; nvalls@clinicauandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors (including pain evaluators and data collectors) will be blinded to group allocation. The anesthesiologist performing the intervention and the patient cannot be blinded due to the nature of the procedure (performance of nerve block). Postoperative care providers will also be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologyst, Anesthesiology Department, Clínica Universidad de Los Andes

Model Details: Randomized, Parallel Assignment, Blinded outcome assessment

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: January 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months and ending 5 years following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the aims of the approved proposal. Proposals should be directed to rcoloma@clinicauandes.cl. To gain access, data requestors will need to sign a data access agreement. Data will be shared after approval by the principal investigator and the institutional review board.

Locations

CL (1)