Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Tendonitis Clinical Trial

Official title:

Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867369
• Other study ID #: 20-01978
• Status: Completed
• Phase: Phase 4
• Start date: July 14, 2021
• Est. completion date: November 11, 2023

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Tendinopathy
• Tendonitis

Intervention

Drug:
• Bupivacaine 20mL 0.5%
Patients in both groups will receive an interscalene nerve block with 20 mL 0.5% bupivacaine.
• Bupivacaine 20mL 0.25%
Participants in the Pecs II block group will receive a Pecs II fascial plane block with 20 mL 0.25% bupivacaine.
• Bupivacaine up to 15mL 0.25%
The Surgical infiltration group patients will receive local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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