Phase 4
Completed N=90
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Post-operative Pain · Total Shoulder Arthroplasty · Osteoarthritis of the Shoulder · Pain Management
Source: ClinicalTrials.gov NCT03887650 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Total Opioid Consumption — 71.25; 90.30 MME — p=0.127
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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
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. Informational only — not medical advice.