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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03273036
Other study ID # ID 03-54-23
Secondary ID
Status Completed
Phase Phase 4
First received August 29, 2017
Last updated September 1, 2017
Start date May 1, 2014
Est. completion date May 1, 2015

Study information

Verified date September 2017
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 1, 2015
Est. primary completion date May 1, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
40 mg Triamcinolone acetate 1 cc
40 mg Triamcinolone acetate 1 cc
Placebos
no injected agent

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ramathibodi Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative morphine consumption Post operative 24 hour of morphine consumption in mg
Secondary Visual analog score (back and leg) 0-10 1 day, 2, 6 ,12, 24 weeks
Secondary Oswestry disability index (ODI 2, 6 ,12, 24 weeks
Secondary MacNab scores 2, 6 ,12, 24 weeks
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