Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Phase 4

Completed

• Conditions: Tendonitis
• Interventions: Drug: Bupivacaine 20mL 0.5%; Drug: Bupivacaine up to 15mL 0.25%; Drug: Bupivacaine 20mL 0.25%

• Registration Number: NCT04867369
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-30
• Study Start: 2021-07-14
• Primary Completion: 2023-11-08
• Study Completion: 2023-11-11
• Disposition First Submitted: 2024-10-31
• Results First Submitted: 2024-11-14
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Results First Posted: 2024-12-13
• Disposition First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical infiltration	Bupivacaine 20mL 0.5%	80 patients scheduled for open biceps tenodesis
Surgical infiltration	Bupivacaine up to 15mL 0.25%	80 patients scheduled for open biceps tenodesis
Pecs II block	Bupivacaine 20mL 0.5%	80 patients scheduled for open biceps tenodesis
Pecs II block	Bupivacaine 20mL 0.25%	80 patients scheduled for open biceps tenodesis

Primary Outcome Measures

Name	Time	Method
Opioid Utilization for the First 24 Hours After Surgery	Up to 24-Hours Post-Operation	Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Reactions to Surgical Subpectoral Incision - Movement	Intraoperative	Number of patients with movement during incision.
Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia	Intraoperative	Number of patients with tachycardia during incision.
Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep	Intraoperative	Number of patients with sensation in bicep during incision.
Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)	Typically 1-3 Hours Post-Operation	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.
Patient-reported Numerical Rating Scale (NRS) Score	Day 3 Post-Operation	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States