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OpenTrials
Completed

NCT Number: NCT03273036

Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40 mg Triamcinolone acetate 1 cc

Drug

40 mg Triamcinolone acetate 1 cc

Placebos

Drug

no injected agent

Primary outcomes

  1. Post-operative morphine consumption

    Time frame: Post operative 24 hour of morphine consumption in mg

Secondary outcomes

  1. Visual analog score (back and leg) 0-10

    Time frame: 1 day, 2, 6 ,12, 24 weeks

  2. Oswestry disability index (ODI

    Time frame: 2, 6 ,12, 24 weeks

  3. MacNab scores

    Time frame: 2, 6 ,12, 24 weeks

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2017
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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