Liposomal Bupivacaine Versus Interscalene Nerve Block
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Interscalene Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
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
Sites / Locations
- University of Cincinnati Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Liposomal Bupivacaine
Interscalene Nerve Block
Arm Description
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).
Patients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine.
Outcomes
Primary Outcome Measures
Opioid Consumption
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Visual Analog Scale Pain Scores
Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
Patient Satisfaction: Rating
Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
Relationship between catastrophizing, pain, and patient satisfaction
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.
Relationship between resilience, pain, and patient satisfaction
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03929146
Brief Title
Liposomal Bupivacaine Versus Interscalene Nerve Block
Official Title
Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
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).
Arm Title
Interscalene Nerve Block
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Exparel
Intervention Description
Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.
Intervention Type
Procedure
Intervention Name(s)
Interscalene Nerve Block
Intervention Description
Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Time Frame
72 hours post-operatively
Title
Visual Analog Scale Pain Scores
Description
Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
Time Frame
72 hours post-operatively
Title
Patient Satisfaction: Rating
Description
Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
Time Frame
72 hours post-operatively
Title
Relationship between catastrophizing, pain, and patient satisfaction
Description
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.
Time Frame
Catastrophizing will be measured pre-operatively
Title
Relationship between resilience, pain, and patient satisfaction
Description
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.
Time Frame
Resilience will be measured pre-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Schumaier, MD
Organizational Affiliation
University of Cincinnati, Department of Orthopaedics and Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Liposomal Bupivacaine Versus Interscalene Nerve Block
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