Liposomal Bupivacaine Versus Interscalene Nerve Block
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03929146|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Exparel Procedure: Interscalene Nerve Block||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)|
|Actual Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: 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).
Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.
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.
Procedure: Interscalene Nerve Block
Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.
- 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)
- 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 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929146
|Contact: Adam Schumaier, MDemail@example.com|
|Contact: Brian Grawe, MDfirstname.lastname@example.org|
|Principal Investigator:||Adam Schumaier, MD||University of Cincinnati, Department of Orthopaedics and Sports Medicine|