Status:
ENROLLING_BY_INVITATION
Exparel v Dexamethasone in RCR
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Rotator Cuff Tears
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with...
Eligibility Criteria
Inclusion
- Participants having a primary rotator cuff repair
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
- Ability to provide informed consent
Exclusion
- Revision rotator cuff repair (RCR) cases
- Participants having an open RCR
- Allergies and/or medical contra-indications to study medications
- Non-English speakers
- Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
- Rotator cuff repair needing Graft Augmentation
- Known alcohol or narcotic abuse history
- Existing contract with a pain specialist due to underlying preoperative pain syndrome
- Preoperative opioid use within the 3 months prior to surgery
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06575010
Start Date
August 26 2024
End Date
August 30 2025
Last Update
August 28 2024
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107