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Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
40 mg Triamcinolone acetate 1 cc
Placebos
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    epidural steroid injection

    placebo injection

    Arm Description

    40 mg triamcinolone acetate 1 cc

    no injection agent

    Outcomes

    Primary Outcome Measures

    Post-operative morphine consumption

    Secondary Outcome Measures

    Visual analog score (back and leg) 0-10
    Oswestry disability index (ODI
    MacNab scores

    Full Information

    First Posted
    August 29, 2017
    Last Updated
    September 1, 2017
    Sponsor
    Ramathibodi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03273036
    Brief Title
    Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy
    Official Title
    Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2014 (Actual)
    Primary Completion Date
    May 1, 2015 (Actual)
    Study Completion Date
    May 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ramathibodi Hospital

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    epidural steroid injection
    Arm Type
    Active Comparator
    Arm Description
    40 mg triamcinolone acetate 1 cc
    Arm Title
    placebo injection
    Arm Type
    Placebo Comparator
    Arm Description
    no injection agent
    Intervention Type
    Drug
    Intervention Name(s)
    40 mg Triamcinolone acetate 1 cc
    Intervention Description
    40 mg Triamcinolone acetate 1 cc
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    no injected agent
    Primary Outcome Measure Information:
    Title
    Post-operative morphine consumption
    Time Frame
    Post operative 24 hour of morphine consumption in mg
    Secondary Outcome Measure Information:
    Title
    Visual analog score (back and leg) 0-10
    Time Frame
    1 day, 2, 6 ,12, 24 weeks
    Title
    Oswestry disability index (ODI
    Time Frame
    2, 6 ,12, 24 weeks
    Title
    MacNab scores
    Time Frame
    2, 6 ,12, 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

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