drugset / Trial / NCT03035656

Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

NCT03035656 ↗

Phase 4 Unknown 228 enrolled Horizon Health Network
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.

Timeline

Start
2019-03-01
Primary completion
2022-03-01
Completion
2022-03-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.2 % Other
Subject Ropivacaine Other / unclassified 10 ml Other

Indications

No indication recorded.