Phase 4 N=90 Randomized Triple-blind Treatment

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

Post-operative Pain · Total Shoulder Arthroplasty · Osteoarthritis of the Shoulder · Pain Management

Bottom Line

View on ClinicalTrials.gov: NCT03887650 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Total Opioid Consumption — 71.25; 90.30 MME — p=0.127

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Liposomal Bupivicaine 1.3% (Drug); Bupivacaine 0.5% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hartford Hospital
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Opioid Consumption	71.25; 90.30	0.127
SECONDARY Time to First Opioid Medication	10.5667; 12.025	.975
SECONDARY Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours	0.00; 0.00; 0.00; 0.00; 2.00; 1.00	.852
SECONDARY Hospital Length-of-stay	31.05; 31.63	.112
SECONDARY Assessment of Patient Overall Satisfaction With Pain Control	32; 24; 9; 17; 4; 1	0.096
SECONDARY Incidence of Distress From Block Numbness	31; 31; 14; 14; 0; 0	1.0
SECONDARY Duration of Sensory Nerve Block	11; 11; 27; 27; 0; 2	.441
SECONDARY Day of the Final Opioids Used	4; 4	.876
SECONDARY Motor Recovery	1; 11; 4; 3; 38; 29	.011 sig

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.

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;
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03887650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.