Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial
Overview
- Phase
- Phase 4
- Intervention
- Liposomal Bupivacaine
- Conditions
- Arthropathy Shoulder
- Sponsor
- Mayo Clinic
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Patient Pain Scores
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Steven J. Hattrup, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Liposomal Bupivacaine
Plain Bupivacaine
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.
Intervention: Bupivacaine Hydrochloride
Outcomes
Primary Outcomes
Patient Pain Scores
Time Frame: 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 Outcomes
- Opioid Consumption(Measured at 72 hours and at 3 weeks post-operatively)
- Time to Cessation of Nerve Blockade(4, 8, 12, 16, 20, 24, and 28 hours post-operatively)
- Satisfaction With Pain Control Using Satisfaction Scale(Measured at 72 hours and at three weeks post-operatively)