RecruitingNot ApplicableNCT07334288

Retrolaminar Analgesia for LuMbar Surgery

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


Sponsor

Universidad de los Andes, Chile

Enrollment

50 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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

Exclusion Criteria10

  • 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

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Interventions

PROCEDUREUltrasound-Guided Retrolaminar Block

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.

OTHERStandard Analgesia

Patients receive standard multimodal analgesia without regional anesthesia block.


Locations(1)

Clínica Universidad de los Andes, Chile

Santiago, Santiago Metropolitan, Chile

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NCT07334288


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