MedTrace Logo

Use of Local Intraoperative Steroid in MIS TLIF

NCT03308084 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-11-20

No results posted yet for this study

Summary

The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).

Conditions

  • Dysphasia

Interventions

DRUG

Methylprednisolone

Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure

DRUG

Dexamethasone

Administration of 10mg Dexamethasone IV intraoperatively

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Kern Singh, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-13
Primary Completion
2019-05-03
Completion
2019-05-03

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308084 on ClinicalTrials.gov