LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus

HHC-2018-0231

This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.

2019-03-11

2022-01-11

2022-03-08

Completed

Early phase I

90

Inclusion Criteria: * Patient age \>18 years; * Lack of language barrier; * Informed consent obtained; * Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon; * American Society of Anesthesiology (ASA) physical status score I- III Exclusion Criteria: * Presence of a language barrier; * Inability to complete telephone and/or paper questionnaire; * Lack of consent; * Allergy to local anesthetic; * Chronic pain syndrome and/or preoperative opioid use \> 50 MME per day (including extended-release formulations and methadone); * Preoperative consultation to chronic pain service; * History of (\<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men); * Baseline peripheral neuropathy of the brachial plexus; * Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site; * Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy; * Weight \< 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V; * Revision arthroplasty; * Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block; * Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-center, prospective, randomized controlled cross-sectional study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2023-09-15