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.

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Drug: 40 mg Triamcinolone acetate 1 cc; Drug: Placebos

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: epidural steroid injection; 40 mg triamcinolone acetate 1 cc	Drug: 40 mg Triamcinolone acetate 1 cc; 40 mg Triamcinolone acetate 1 cc
PLACEBO_COMPARATOR: placebo injection; no injection agent	Drug: Placebos; no injected agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative morphine consumption	Post operative 24 hour of morphine consumption in mg

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual analog score (back and leg) 0-10	1 day, 2, 6 ,12, 24 weeks
Oswestry disability index (ODI	2, 6 ,12, 24 weeks
MacNab scores	2, 6 ,12, 24 weeks

Collaborators and Investigators

• Sponsor: Ramathibodi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (ACTUAL): September 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: ID 03-54-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No