Liposomal Bupivacaine Versus Interscalene Nerve Block
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|ClinicalTrials.gov Identifier: NCT03929146|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|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, MDfirstname.lastname@example.org|
|Contact: Brian Grawe, MDemail@example.com|
|United States, Ohio|
|University of Cincinnati Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Adam Schumaier 513-558-1109 firstname.lastname@example.org|
|Contact: Brian Grawe 5135581109 email@example.com|
|Principal Investigator:||Adam Schumaier, MD||University of Cincinnati, Department of Orthopaedics and Sports Medicine|