Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Tendonitis

Treatments: Drug: Bupivacaine 20mL 0.25%; Drug: Bupivacaine 20mL 0.5%; Drug: Bupivacaine up to 15mL 0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT04867369

20-01978

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Pecs II block

Experimental group

Description:

80 patients scheduled for open biceps tenodesis

Treatment:

Drug: Bupivacaine 20mL 0.5%

Drug: Bupivacaine 20mL 0.25%

Surgical infiltration

Active Comparator group

Description:

80 patients scheduled for open biceps tenodesis

Treatment:

Drug: Bupivacaine up to 15mL 0.25%

Drug: Bupivacaine 20mL 0.5%