Lumbar Disc Herniation
Conditions
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.
Interventions
DRUGEpidural 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.
DRUGPlacebo
The placebo is soaked with NSS in the gelfoam size 1x2 cm as well and applied on the epidura before removal of the endoscope.
Sponsors
Queen Savang Vadhana Memorial Hospital, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 3rd month | To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes | POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr | ODI, VAS of leg pain, VAS of back pain, Modified Macnab score |
| Postoperative outcomes | POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr | Time at first dose analgesia, Post-op opioid consumption, complication, time return to work |
Countries
Thailand
Contacts
Primary ContactSurachat Jaroenwareekul, M.D.
Backup ContactKhanathip Jitphakdee, M.D.
Outcome results
None listed