Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

NYU Langone Health160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Tendonitis

Interventions

Bupivacaine 20mL 0.5%DRUG

Interscalene nerve block with 20 mL 0.5% bupivacaine.

Bupivacaine 20mL 0.25%DRUG

Pecs II fascial plane block with 20 mL 0.25% bupivacaine.

Bupivacaine up to 15mL 0.25%DRUG

Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Opioid Utilization for the First 24 Hours After Surgery

Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.

Time frame: Up to 24-Hours Post-Operation

Secondary Outcomes

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.

Time frame: Typically 1-3 Hours Post-Operation

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.

Time frame: 24 Hours Post-Operation

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.

Time frame: Day 3 Post-Operation

Number of Patients With Reactions to Surgical Subpectoral Incision - Movement

Number of patients with movement during incision.

Time frame: Intraoperative

Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia

Number of patients with tachycardia during incision.

Time frame: Intraoperative

Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep

Number of patients with sensation in bicep during incision.

Data from ClinicalTrials.gov

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