Liposomal Bupivacaine Versus Interscalene Nerve Block

Pain, Postoperative Clinical Trial

Official title:

Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929146
• Other study ID #: 2017-7698
• Status: Completed
• Phase: Phase 4
• Start date: February 5, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Exparel
Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.

Procedure:
• Interscalene Nerve Block
Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)	72 hours post-operatively
Primary	Visual Analog Scale Pain Scores	Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)	72 hours post-operatively
Primary	Patient Satisfaction: Rating	Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)	72 hours post-operatively
Primary	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.	Catastrophizing will be measured pre-operatively
Primary	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.	Resilience will be measured pre-operatively