Measuring Opioid Use After Rotator Cuff Repair: Comparing the Effects of Standard vs. Extended-release Nerve Blocks

• Status: Completed
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The investigators aim to determine if a longer acting nerve block, which is a local anesthetic, can help reduce opioid use after surgery in patients that are getting rotator cuff repair surgery. The investigators will also determine if the longer acting block can reduce the number of days that opioids are taken after surgery. Patients that schedule this type of surgery will be given information regarding the study and asked if they want to participate. If they do, they will be randomized to either receive the standard nerve block or the longer acting nerve block. Participants and physicians will not know which nerve block the participants are receiving. Participants will receive a standard pain medication prescription after surgery and will be asked to record pain scores, medications taken and satisfaction level every day in a journal for two weeks. Participants will be asked to bring in their medication bottles and pain journal to the 2-week follow up appointment. Participants' pain scores will be assessed in the office at the follow up appointment and study staff will conduct a pill count. Participants will return for a 6-week follow up appointment and pain scores will be assessed again at that time, and another pill count will be conducted. At this point the study will be complete.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carilion Clinic
• Collaborator: Virginia Polytechnic Institute and State University
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. At least 18 years of age at time of enrollment

2. Be scheduled for Arthroscopic Rotator Cuff Repair (ARCR) surgery with associated pathology (CPT code 29827 + associated codes)

3. Be scheduled for ARCR surgery for primary repair

4. Be scheduled for ARCR surgery to be performed at Roanoke Ambulatory Surgery Center (RASC) by a surgeon participating in the study

5. Is willing to fill out the pain diary

6. Is able to read, understand, and sign the informed consent document

7. Is able to read and understand the patient-reported measures that will be collected via the pain diary and phone calls

Exclusion Criteria:

1. American Society of Anesthesiologists (ASA) status IIIb or greater.

ASA status III is characterized by:

• A patient with severe systemic disease, e.g., Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of MI, CVA, TIA, or CAD/stents.

According to Dr. TK Miller and Anesthesiologists at RASC, there is an unwritten standard that patients characterized as ASA status III that have stable, long term disease can be operated on at free-standing ambulatory surgery centers. Broken down into ASA IIIa and ASA IIIb.

• ASA IIIa represents ASA status III patients that are assessed by anesthesia and deemed stable enough to operate on at a free-standing ambulatory surgery center.

• ASA IIIb represents ASA status III patients that are assessed by anesthesia and deemed not stable enough to operate on at a free-standing ambulatory surgery center.

Examples of individuals that would classify as ASA IIIa include:

• Someone who has a history of longstanding diabetes that is well managed.

• Someone who is status post cardiac stent(s) and has had no chest pain or angina since the stents have been placed and has been cleared by their cardiologist to go back to full activity.

Examples of individuals that would classify as ASA IIIb include:

• Someone who has a history of longstanding diabetes that is poorly managed.

• Someone who is status post cardiac stent(s) and has had chest pain or angina since the stents have been placed and has not been cleared by their cardiologist to go back to full activity.

2. Currently pregnant

3. Documented opioid use within 30 days prior to surgery

4. Revision ARCR surgery

5. Currently taking opioid medication for chronic pain management

6. History of documented substance abuse or related disorders

7. Currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study

8. Allergic reactions to amide anesthetics

9. Neurologic deficit or disability involving the surgical extremity

10. Unwilling or unable to consent

11. History of cognitive or mental health status that would interfere with study participation