Comparative Outcomes of Intraoperative Epidural Application of Anesthetic Cocktail Following Endoscopic Lumbar Discectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index (ODI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Epidural Anesthetic Cocktail
Patients which received epidural anesthetic cocktail following endoscopic discectomy
Intervention: Epidural Anesthetic Cocktail (Drug)
Placebo
Patients which received placebo following endoscopic discectomy
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Oswestry Disability Index (ODI)
Time Frame: 3rd month
To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months
Secondary Outcomes
- Functional Outcomes(POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr)
- Postoperative outcomes(POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr)