RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Drug: Epidural Anesthetic Cocktail
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were divided into two groups using computer-generated block-of-four randomization. The experimental group received epidural anesthetic cocktail following endoscopic discectomy, while the control group received placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Anesthetic Cocktail<br>Patients which received epidural anesthetic cocktail following endoscopic discectomy | Drug: Epidural Anesthetic Cocktail<br>* 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.<br>* Other names: Cocktail;|
| Placebo Comparator: Placebo<br>Patients which received placebo following endoscopic discectomy | Drug: Placebo<br>* The placebo is soaked with NSS in the gelfoam size 1x2 cm as well and applied on the epidura before removal of the endoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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