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

Hartford Hospital1 site in 1 country90 target enrollmentMarch 11, 2019

ConditionsPost-operative Pain Total Shoulder Arthroplasty Osteoarthritis of the Shoulder Pain Management

InterventionsLiposomal Bupivicaine 1.3%Bupivacaine 0.5%

DrugsLiposomal Bupivicaine 1.3%Bupivacaine 0.5%

Overview

Phase: Phase 4
Intervention: Liposomal Bupivicaine 1.3%
Conditions: Post-operative Pain
Sponsor: Hartford Hospital
Enrollment: 90
Locations: 1
Primary Endpoint: Total Opioid Consumption
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 11, 2019

End Date

March 8, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hartford Hospital

Responsible Party

Principal Investigator

Kevin Finkel

Principal Investigator

Hartford Hospital

Eligibility Criteria

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;

Arms & Interventions

Liposomal Bupivacaine 1.3%

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

Intervention: Liposomal Bupivicaine 1.3%

Bupivacaine 0.5% with Adjuncts

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

Intervention: Bupivacaine 0.5%

Outcomes

Primary Outcomes

Total Opioid Consumption

Time Frame: Up to 120 postoperative hours

Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)

Secondary Outcomes

Time to First Opioid Medication(from the time of the block injection until discharge, assessed up to 72 postoperative hours.)
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours(24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60)
Hospital Length-of-stay(From the date of admission until discharge, assessed up to 72 hours.)
Assessment of Patient Overall Satisfaction With Pain Control(POD4 - 60 days)
Incidence of Distress From Block Numbness(At PACU and Postoperative day 2)
Duration of Sensory Nerve Block(Day 1, after Day 1 (day 2 to 60), and at postoperative day 60)
Day of the Final Opioids Used(0-96 postoperative hours)
Motor Recovery(PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.)