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Completed

NCT Number: NCT04867369

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.

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Key information

Conditions

Tendonitis Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Opioid Utilization for the First 24 Hours After Surgery

    Time frame: Up to 24-Hours Post-Operation

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

Secondary outcomes

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

    Time frame: Typically 1-3 Hours Post-Operation

    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.

  2. Patient-reported Numerical Rating Scale (NRS) Score

    Time frame: 24 Hours Post-Operation

    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.

  3. Patient-reported Numerical Rating Scale (NRS) Score

    Time frame: Day 3 Post-Operation

    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.

  4. Number of Patients With Reactions to Surgical Subpectoral Incision - Movement

    Time frame: Intraoperative

    Number of patients with movement during incision.

  5. Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia

    Time frame: Intraoperative

    Number of patients with tachycardia during incision.

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

    Time frame: Intraoperative

    Number of patients with sensation in bicep during incision.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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