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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: Analgesics; Epinephrine; Epinephryl borate; Morphine; Pharmaceutical Solutions; Racepinephrine; Ropivacaine

Criteria

Inclusion Criteria:

• Patients who sustained an acute femur fracture in any anatomic region (subcapital, basicervical, intertrochanteric, subtrochanteric, diaphyseal, distal metaphyseal, or distal articular)

• Age ≥18 years

• Indicated for definitive operative management at a single Level 1 trauma center

Exclusion Criteria:

• Revision procedures

• Temporizing procedures (irrigation and debridement, external fixation)

• Regular narcotic use

• Psychiatric illness

• Dementia

• Neuromuscular deficit

• Allergy/intolerance to cocktail ingredients

• Clinical status that precludes verbal pain assessment (e.g. major intracranial trauma)

• Refusal to participate