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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
The Bone and Joint Institute at Hartford Hospital
Hartford, Connecticut, United States
Total Opioid Consumption
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Time frame: Up to 120 postoperative hours
Time to First Opioid Medication
From block time to the first dose of opioids given, measured in hours.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: POD4 - 60 days
Incidence of Distress From Block Numbness
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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) 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.
Time frame: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.