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Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures: A Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Ropivacaine, Epinephrine, and 2 other interventions for Pain, Postoperative and Femur Fracture. Completed, enrolled 102 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
400 mg of 0.75% ropivacaine (53.33 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
0.6 mg of 1 mg/mL epinephrine (0.6 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
5 mg of 0.5 mg/mL morphine sulfate (10 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
36.07 mL 0.9% sodium chloride solution will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.