drugset / Trial / NCT03308084

Use of Local Intraoperative Steroid in MIS TLIF

NCT03308084 ↗

Phase 3 Completed 105 enrolled Rush University Medical Center
RandomizedParallel-groupSingle-blindPrevention

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).

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 80 mg Other
Comparator Dexamethasone Small molecule 10 mg Intravenous