drugset / Trial / NCT02793947

Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures

NCT02793947

Phase 4 Completed 102 enrolled University of Iowa
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of a peri-incisional multimodal injection for post-operative pain control following operative management of femur fractures. Enrolled subjects will be prospectively randomized into either the peri-incisional injection or control cohorts. Patients will be treated with standard of care surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into the injection cohort will receive an intra-operative injection with 400 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Visual analog pain scores will be collected every 4 hours after surgery for the first two post-operative days. Total narcotic consumption will also be recorded over eight hour intervals for the first two post-operative days. Medication related side effects will be monitored. The investigators hypothesize that the peri-incisional injection cohort will demonstrate an improved pain profile and utilize less parenteral narcotic analgesia in the early post-operative period.

Timeline

Start
2015-05
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Epinephrine Other / unclassified 0.6 mg Other
Subject Morphine Other / unclassified 5 mg Other
Subject Ropivacaine Other / unclassified 400 mg Other

Indications