Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
Condition: Pain, Postoperative; Ankle Fractures
MeSH terms: Pain, Postoperative; Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Periarticular fractures (bone breaks extending into the joint surface) treated by orthopaedic
      surgeons are associated with significant pain in the post-operative period, often requiring
      high doses of opioid analgesics. In recent years, the high risk of misuse, abuse, and death
      associated with prescription opioid use has become increasingly evident.

      Although physicians are being advised to avoid administration of opioid prescriptions,
      alternative pain management options are limited. Currently, there is a need to investigate
      different pain management models in order to provide safe and effective pain relief during
      the post-operative period. The investigators aim to evaluate the effectiveness of
      peri-incisional multimodal injections as an alternative post-operative pain control method in
      orthopaedic trauma patients with operative ankle fractures. Approximately 200 patients will
      be randomized to either receive or not receive intra-operative injections in addition to
      standard opioid analgesic regimens. Post-operative pain management outcomes will be assessed
      and compared between the 2 study groups to determine effectiveness of the injections. The
      proposed study will build upon related work to advance post-operative pain control regimens
      in orthopaedic surgery. Goals include the reduction of unnecessary patient suffering,
      reliance on opioids, and length of stay, while improving patient experience. These aims will
      be accomplished through the expansion of currently used multimodal periarticular injections
      from populations undergoing elective surgery to orthopaedic trauma patients with rotational
      ankle fractures.

      The study design is a prospective, double-blinded, randomized controlled trial. Patients
      included in the study will be randomly assigned to one of two treatment groups:
      intra-operative multimodal periarticular injection or control (no injection). The
      peri-incisional injection will consist of ropivacaine, epinephrine, and morphine. All
      pharmacologic agents in the anesthetic cocktail are FDA approved and have been previously
      used in combination during other types of orthopaedic surgeries.

      All patients included in the study will receive standard post-operative opioid analgesic
      regimens, administered 'per needed', regardless of their assigned treatment group per study
      protocol. ≥ 40 patients will be randomly assigned to each group. The patients enrolled in the
      investigation as well as health care professionals performing post-operative assessments and
      collecting data will be blinded to treatment allocation. The feasibility of multimodal
      peri-incisional injections is supported by their current efficacy in populations undergoing
      elective orthopedic surgeries. These injections may be equally effective at reducing pain
      compared to regional anesthesia with continuous infusions, and single-shot nerve blocks.

      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.
    

Intervention name(s): Ropivacaine; Epinephrine; Morphine; 0.9% sodium chloride solution
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Naropin; Adrenalin; Duramorph; 0.9% normal saline
Intervention MeSH terms: Epinephrine; Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment