Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
Condition: Pain, Postoperative; Femur Fracture
MeSH terms: Pain, Postoperative; Fractures, Bone; Femoral Fractures
Intervention: Ropivacaine; Epinephrine; Morphine; 0.9% sodium chloride solution
Intervention description: 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.
Intervention MeSH terms: Epinephrine; Morphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peri-incisional injection; Multimodal analgesia; Femur fracture

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.
    

Eligibility 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