Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)
Overview
- Phase
- Phase 4
- Intervention
- Exparel
- Conditions
- Pain, Postoperative
- Sponsor
- University of Cincinnati
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Patient Satisfaction: Rating
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.
Investigators
Adam Schumaier
Principal Investigator
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •patients who are older than 18 years
- •patients undergoing reverse total shoulder arthroplasty
Exclusion Criteria
- •pregnancy
- •inability to provide informed consent
- •deemed unreliable for follow-up survey completion
- •individuals who do not speak English
- •those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease
Arms & Interventions
Liposomal Bupivacaine
Patients in this group will receive a single intra-operative injection of liposomal bupivacaine near the surgical site (40 ml total: consisting of 20 ml 1.3% liposomal bupivacaine and 20 ml normal saline).
Intervention: Exparel
Interscalene Nerve Block
Patients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine.
Intervention: Interscalene Nerve Block
Outcomes
Primary Outcomes
Patient Satisfaction: Rating
Time Frame: 72 hours post-operatively
Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
Relationship between resilience, pain, and patient satisfaction
Time Frame: Resilience will be measured pre-operatively
The effect of patient resilience (measured using the Brief Resilience Scale) on post-operative pain control and satisfaction. The Brief Resilience Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 1 to a maximum score of 5. Higher scores on the Brief Resilience Scale indicate greater resilience. The patients' resilience scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between resilience with pain control and satisfaction.
Opioid Consumption
Time Frame: 72 hours post-operatively
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Visual Analog Scale Pain Scores
Time Frame: 72 hours post-operatively
Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
Relationship between catastrophizing, pain, and patient satisfaction
Time Frame: Catastrophizing will be measured pre-operatively
The effect of patient catastrophizing (measured using the Pain Catastrophizing Scale) on post-operative pain control and satisfaction. The Pain Catastrophizing Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 0 to a maximum score of 52. Higher scores on the Pain Catastrophizing Scale indicate more catastrophic thinking. The patients' catastrophizing scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between catastrophizing with pain control and satisfaction.