Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

NCT04867369 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-01978
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendonitis

Outcome Measures

Primary Outcomes (1)

• Opioid Utilization for the First 24 Hours After Surgery

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

  Up to 24-Hours Post-Operation

Secondary Outcomes (6)

• Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)

  Typically 1-3 Hours Post-Operation

• Patient-reported Numerical Rating Scale (NRS) Score

  24 Hours Post-Operation

• Patient-reported Numerical Rating Scale (NRS) Score

  Day 3 Post-Operation

• Number of Patients With Reactions to Surgical Subpectoral Incision - Movement

  Intraoperative

• Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia

  Intraoperative

Study Arms (2)

Pecs II block

EXPERIMENTAL

80 patients scheduled for open biceps tenodesis

Drug: Bupivacaine 20mL 0.5%; Drug: Bupivacaine 20mL 0.25%

Surgical infiltration

ACTIVE COMPARATOR

80 patients scheduled for open biceps tenodesis

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

Interventions

Bupivacaine 20mL 0.5% DRUG

Interscalene nerve block with 20 mL 0.5% bupivacaine.

Pecs II block; Surgical infiltration

Bupivacaine 20mL 0.25% DRUG

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

Pecs II block

Bupivacaine up to 15mL 0.25% DRUG

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

Surgical infiltration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 75 years of age
• Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Arthur Hertling, MD
• Organization: NYU Langone Health

arthur.hertling@nyulangone.org

212-598-6085

Study Officials

• Arthur Hertling, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 30, 2021
• Study Start: July 14, 2021
• Primary Completion: November 8, 2023
• Study Completion: November 11, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required.
• Access Criteria: Requests may be directed to Uchenna.Umeh@nyulangone.org.

Locations

US (1)