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Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03273036
Enrollment
30
Registered
2017-09-06
Start date
2014-05-01
Completion date
2015-05-01
Last updated
2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation

Brief summary

The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.

Detailed description

To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo

Interventions

DRUG40 mg Triamcinolone acetate 1 cc

40 mg Triamcinolone acetate 1 cc

DRUGPlacebos

no injected agent

Sponsors

Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed

Exclusion criteria

* Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid

Design outcomes

Primary

MeasureTime frame
Post-operative morphine consumptionPost operative 24 hour of morphine consumption in mg

Secondary

MeasureTime frame
Visual analog score (back and leg) 0-101 day, 2, 6 ,12, 24 weeks
Oswestry disability index (ODI2, 6 ,12, 24 weeks
MacNab scores2, 6 ,12, 24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026