RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Enrolling

Conditions: Lumbar Disc Herniation

Treatments: Drug: Epidural Anesthetic Cocktail; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05738759

013/2565

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Epidural Anesthetic Cocktail

Experimental group

Description:

Patients which received epidural anesthetic cocktail following endoscopic discectomy

Treatment:

Drug: Epidural Anesthetic Cocktail

Placebo

Placebo Comparator group

Description:

Patients which received placebo following endoscopic discectomy

Treatment:

Drug: Placebo