Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

Phase 4

Completed

Brief Summary: The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.

Detailed Description: This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal Bupivacaine	Administered utilizing ultrasound guidance by an anesthesiologist. Study patients will receive 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.
Plain Bupivacaine	Bupivacaine Hydrochloride	Peripheral nerve blocks will be performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride will be utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block will be utilized. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.

Primary Outcome Measures

Name	Time	Method
Patient Pain Scores	72 hours post-operatively	Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	Measured at 72 hours and at 3 weeks post-operatively	Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks
Time to Cessation of Nerve Blockade	4, 8, 12, 16, 20, 24, and 28 hours post-operatively	Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
Satisfaction With Pain Control Using Satisfaction Scale	Measured at 72 hours and at three weeks post-operatively	Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.