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Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

NCT ID: NCT03273036

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2015-05-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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epidural steroid injection

40 mg triamcinolone acetate 1 cc

Group Type ACTIVE_COMPARATOR

40 mg Triamcinolone acetate 1 cc

Intervention Type DRUG

40 mg Triamcinolone acetate 1 cc

placebo injection

no injection agent

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

no injected agent

Interventions

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40 mg Triamcinolone acetate 1 cc

40 mg Triamcinolone acetate 1 cc

Intervention Type DRUG

Placebos

no injected agent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jatupon Kongtharvonskul

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ID 03-54-23

Identifier Type: -

Identifier Source: org_study_id

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