Clinical trial NCT05738759: RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy
Official title: Comparative Outcomes of Intraoperative Epidural Application of Anesthetic Cocktail Following Endoscopic Lumbar Discectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 3rd month
Secondary outcomes:
measure: Functional Outcomes
timeFrame: POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
measure: Postoperative outcomes
timeFrame: POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
Study officials:
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