Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial

201608737

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.

2016-10-01

2018-09-21

2018-09-21

Completed

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-12-15