RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

Last updated: April 2, 2024
Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Radiculopathy

Treatment

Epidural Anesthetic Cocktail

Placebo

Clinical Study ID

NCT05738759
013/2565
  • Ages 18-60
  • All Genders

Study Summary

The study aims to study the effect of intraoperative epidural application of anesthetic cocktail following endoscopic lumbar discectomy in improving postoperative pain, length of hospital stay, time at first dose analgesia, post-operative opioid consumption, functional outcomes, time return to work, and postoperative complications

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-60
  • Lumbar radiculopathy
  • No prior spinal surgery or recurrent lumbar disc herniation
  • Plan for endoscopic discectomy after failed conservative for at least 6 weeks
  • Single-level herniation confirmed by MRI which correlated with symptoms

Exclusion

Exclusion Criteria:

  • Allergic or contraindicated to amide-type anesthesia, opioid, NSAIDs, or steroids
  • Cauda equina syndrome
  • Concomitant with other abnormalities
  • Unable to answer questionnaires
  • Cannot tolerate surgery due to medical comorbidities

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Epidural Anesthetic Cocktail
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
December 30, 2024

Study Description

This is a randomized controlled trial study the effects of epidural anesthetic cocktail. The cocktail, consists of triamcinolone 40 mg, marcaine 5 mg, and morphine 3 mg, is soaked in the gelfoam size 1x2 cm and applied on the epidura before removal of the endoscope. 54 participants are deivided into two arms, experimental and placebo group, and randomized into the trial. Primary objective is the ODI score from patient-reported function outcome at 3 months with secondary objective as mentioned above.

Connect with a study center

  • Queen Savang Vadhana Memorial Hospital

    Chon Buri, 20110
    Thailand

    Active - Recruiting

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