Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

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 Overview

• Status: Completed
• Conditions: Tendonitis
• Intervention / Treatment: Drug: Bupivacaine 20mL 0.5%; Drug: Bupivacaine 20mL 0.25%; Drug: Bupivacaine up to 15mL 0.25%

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pecs II block; 80 patients scheduled for open biceps tenodesis	Drug: Bupivacaine 20mL 0.5%; Interscalene nerve block with 20 mL 0.5% bupivacaine.; Drug: Bupivacaine 20mL 0.25%; Pecs II fascial plane block with 20 mL 0.25% bupivacaine.
Active Comparator: Surgical infiltration; 80 patients scheduled for open biceps tenodesis	Drug: Bupivacaine 20mL 0.5%; Interscalene nerve block with 20 mL 0.5% bupivacaine.; Drug: Bupivacaine up to 15mL 0.25%; Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of Patients With Reactions to Surgical Subpectoral Incision - Movement	Number of patients with movement during incision.	Intraoperative
Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia	Number of patients with tachycardia during incision.	Intraoperative
Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep	Number of patients with sensation in bicep during incision.	Intraoperative

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Arthur Hertling, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 20-01978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Uchenna.Umeh@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required.
• IPD Sharing Access Criteria: Requests may be directed to Uchenna.Umeh@nyulangone.org.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes