LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

Phase 4

Completed

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

Interventions: Drug: Bupivacaine 0.5%
Drug: Liposomal Bupivicaine 1.3%

Registration Number: NCT03887650

Lead Sponsor: Hartford Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine 0.5% with Adjuncts	Bupivacaine 0.5%	20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Liposomal Bupivacaine 1.3%	Liposomal Bupivicaine 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

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption	Up to 120 postoperative hours	Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)

Secondary Outcome Measures

Name	Time	Method
Time to First Opioid Medication	from the time of the block injection until discharge, assessed up to 72 postoperative hours.	From block time to the first dose of opioids given, measured in 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	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.
Hospital Length-of-stay	From the date of admission until discharge, assessed up to 72 hours.	From the date and time of admission to the date and time of discharge, Measured in hours.
Assessment of Patient Overall Satisfaction With Pain Control	POD4 - 60 days	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.
Incidence of Distress From Block Numbness	At PACU and Postoperative day 2	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.
Duration of Sensory Nerve Block	Day 1, after Day 1 (day 2 to 60), and at postoperative day 60	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 of the Final Opioids Used	0-96 postoperative hours	The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.
Motor Recovery	PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.	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) 1. Detectable contraction (visible or palpation), but no movement achieved 2. Limb movement achieved, but unable to move against gravity 3. Limb movement against the resistance of gravity 4. Limb movement against gravity and external resistance 5. 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.