NCT05738759

RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

Comparative Outcomes of Intraoperative Epidural Application of Anesthetic Cocktail Following Endoscopic Lumbar Discectomy: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
DRUG	Epidural Anesthetic Cocktail	The anesthetic 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.
DRUG	Placebo	The placebo is soaked with NSS in the gelfoam size 1x2 cm as well and applied on the epidura before removal of the endoscope.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-07-31
• Completion: 2024-12-30
• First posted: 2023-02-22
• Last updated: 2024-04-04

Locations

1 site across 1 country: Thailand