LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

Hartford Hospital

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain; Osteoarthritis of the Shoulder; Total Shoulder Arthroplasty; Pain Management

Treatments: Drug: Bupivacaine 0.5%; Drug: Liposomal Bupivicaine 1.3%

Study type: Interventional

Funder types: Other

Identifiers

NCT03887650

HHC-2018-0231

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Liposomal Bupivacaine 1.3%

Experimental group

Description:

10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block

Treatment:

Drug: Liposomal Bupivicaine 1.3%

Bupivacaine 0.5% with Adjuncts

Active Comparator group

Description:

20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block

Treatment:

Drug: Bupivacaine 0.5%