RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

Not Applicable

Recruiting

• Conditions: Lumbar Disc Herniation
• Interventions: Drug: Epidural Anesthetic Cocktail; Drug: Placebo

• Registration Number: NCT05738759
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-02-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Anesthetic Cocktail	Epidural Anesthetic Cocktail	Patients which received epidural anesthetic cocktail following endoscopic discectomy
Placebo	Placebo	Patients which received placebo following endoscopic discectomy

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	3rd month	To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months

Secondary Outcome Measures

Name	Time	Method
Functional Outcomes	POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr	ODI, VAS of leg pain, VAS of back pain, Modified Macnab score
Postoperative outcomes	POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr	Time at first dose analgesia, Post-op opioid consumption, complication, time return to work

Trial Locations

Locations (1)

Queen Savang Vadhana Memorial Hospital; 🇹🇭 Chon Buri, Thailand