LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Liposomal Bupivicaine 1.3%
* Drug: Bupivacaine 0.5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center, prospective, randomized controlled cross-sectional study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine 1.3%<br>10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block | Drug: Liposomal Bupivicaine 1.3%<br>* 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block<br>|
| Active Comparator: Bupivacaine 0.5% with Adjuncts<br>20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block | Drug: Bupivacaine 0.5%<br>* 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block<br>* Other names: dexamethasone preservative-free;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs) | Up to 120 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Opioid Medication | From block time to the first dose of opioids given, measured in hours. | 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 | Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain. | 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60 | 
| Hospital Length-of-stay | From the date and time of admission to the date and time of discharge, Measured in hours. | From the date of admission until discharge, assessed up to 72 hours. | 
| Assessment of Patient Overall Satisfaction With Pain Control | Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate. | POD4 - 60 days | 
| Incidence of Distress From Block Numbness | On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day. | At PACU and Postoperative day 2 | 
| Duration of Sensory Nerve Block | Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60. | Day 1, after Day 1 (day 2 to 60), and at postoperative day 60 | 
| Day of the Final Opioids Used | The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours. | 0-96 postoperative hours | 
| Motor Recovery | The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation) Detectable contraction (visible or palpation), but no movement achieved Limb movement achieved, but unable to move against gravity Limb movement against the resistance of gravity Limb movement against gravity and external resistance Normal strength The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data. | PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachial Plexus, Liposomal Bupivacaine, Dexamethasone, Interscalene, Bupivacaine, Shoulder Arthroplasty, Regional anesthesia, Exparel