Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
Condition: Pain, Postoperative; Ankle Fractures
MeSH terms: Pain, Postoperative; Fractures, Bone; Ankle Fractures
Intervention: Ropivacaine; Epinephrine; Morphine; 0.9% sodium chloride solution
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: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of a peri-articular
      multimodal injection for post-operative pain control following operative management of
      closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or
      not receive intra-operative injections in addition to standard opioid analgesic regimens.
      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 a 25cc intra-operative injection with 200 mg ropivacaine,
      0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional
      tissues while under general anesthesia. Total post-operative opioid consumption expressed in
      morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from
      operation conclusion to discharge and discharge disposition (to where the patient is
      discharged) will also be recorded. Post-operative pain scores will be assessed and recorded
      in the immediate post-operative period and every 4 hours subsequently until the patient is
      discharged. Medication related side effects will be monitored. The investigators hypothesize
      that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter
      length of stay, and be more likely to discharge to home following surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All consenting patients 18 years of age and older with operative, closed, rotational
             ankle fractures treated with internal fixation.

        Exclusion Criteria:

          -  Patients with any of the following:

               -  Allergy or medical contraindication to any of the study medications

               -  Pregnant women

               -  Diagnosed dementia

               -  Preexisting opioid or illicit drug dependency

               -  Major neuromuscular deficit

               -  Severe systemic disorder (heart failure, respiratory failure, kidney failure,
                  liver failure, or a clotting disorder)

               -  Major head trauma

               -  Concomitant distracting injury

               -  Other surgical intervention in the study period (1 week)

               -  Revision operations

               -  Insists to receive peripheral nerve blocks for surgical anesthesia

               -  Refusal to participate