Overview

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

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Iowa
Treatments:
Analgesics
Epinephrine
Epinephryl borate
Morphine
Pharmaceutical Solutions
Racepinephrine
Ropivacaine