Phase 4
N=160
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Tendonitis
Bottom Line
View on ClinicalTrials.gov: NCT04867369 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Opioid Utilization for the First 24 Hours After Surgery — 17.5; 20 morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine 20mL 0.5% (Drug); Bupivacaine 20mL 0.25% (Drug); Bupivacaine up to 15mL 0.25% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Utilization for the First 24 Hours After Surgery |
17.5; 20 | — |
| SECONDARY Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) |
0.5; 0 | — |
| SECONDARY Patient-reported Numerical Rating Scale (NRS) Score |
1.5; 3 | — |
| SECONDARY Patient-reported Numerical Rating Scale (NRS) Score |
1.5; 3 | — |
| SECONDARY Number of Patients With Reactions to Surgical Subpectoral Incision - Movement |
19; 17 | — |
| SECONDARY Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia |
14; 19 | — |
| SECONDARY Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep |
30; 32 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients between 18 and 75 years of age
- Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis
Exclusion Criteria
- Patients younger than 18 and older than 75;
- Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
- Patients who are allergic to oxycodone;
- Patients with diagnosed or self-reported cognitive dysfunction;
- Patients with a history of neurologic disorder that can interfere with pain sensation;
- Patients with a history of drug or recorded alcohol abuse;
- Patients who are unable to understand or follow instructions;
- Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- Patients with a BMI over 45;
- Any patient that the investigators feel cannot comply with all study related procedures;
- NYU Langone Health students, residents, faculty or staff members.
Data sourced from ClinicalTrials.gov (NCT04867369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.