Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT04182997
Phase
PHASE4
Status
Recruiting
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Conditions

  • Lumbar Disc Herniation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
  • saline 0.9% — DRUG
    Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.

Study Details

The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.

Key Dates

Start date
Nov 21, 2019
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Group
    Patients in this group will be given the placebo (sterile saline).
  • Active Comparator: Dexamethasone Group
    Patients in this group will be given the study drug (dexamethasone).

Primary Outcome Measure

Post Operative Pain Scores [ Time Frame: Until final follow up (up to 8 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Missouri Orthopaedic InstituteColumbiaMissouri65202
Vicki Jones, MEd,CCRP
[email protected]
573-882-7583
Don Moore, MD (PRINCIPAL_INVESTIGATOR)
Theodore Choma, MD (SUB_INVESTIGATOR)

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Missouri Orthopaedic Institute· Columbia, MO

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