Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273036
• Other study ID #: ID 03-54-23
• 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
• 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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation

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