Tendonitis Clinical Trial
Official title:
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Verified date | May 2024 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.
Status | Completed |
Enrollment | 160 |
Est. completion date | November 11, 2023 |
Est. primary completion date | November 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients between 18 and 75 years of age 2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis Exclusion Criteria: 1. Patients younger than 18 and older than 75; 2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer; 3. Patients who are allergic to oxycodone; 4. Patients with diagnosed or self-reported cognitive dysfunction; 5. Patients with a history of neurologic disorder that can interfere with pain sensation; 6. Patients with a history of drug or recorded alcohol abuse; 7. Patients who are unable to understand or follow instructions; 8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; 9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; 10. Patients with a BMI over 45; 11. Any patient that the investigators feel cannot comply with all study related procedures; 12. NYU Langone Health students, residents, faculty or staff members. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid utilization for the first 24 hours after surgery | Opioid utilization is calculated as oxycodone equivalent; measurement includes opioid utilization during surgery. | 24-Hours Post-Operation | |
Secondary | Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Typically 1-3 Hours Post-Operation, Day 1 | |
Secondary | Patient-reported Numerical Rating Scale (NRS) Score | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | 24 Hours Post-Operation | |
Secondary | Patient-reported Numerical Rating Scale (NRS) Score | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Day 1 Post-Operation | |
Secondary | Patient-reported Numerical Rating Scale (NRS) Score | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Day 3 Post-Operation | |
Secondary | Number of patients with reactions to surgical subpectoral incision | Signs include patient movement, tachycardia, etc. | Day 3 Post-Operation | |
Secondary | Number of patients with presence of sensation in PACU | Skin testing in the axilla (distal to surgical dressing) will be done in PACU prior to discharge to evaluate the presence or absence of sensation to cold and pinprick in that area. | Typically 1-3 Hours Post-Operation, Day 1 |
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