CompletedPhase 4

Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

United States160 participantsStarted 2021-07-14

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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;

What they're measuring

Opioid Utilization for the First 24 Hours After Surgery

Timeframe: Up to 24-Hours Post-Operation

Trial details

NCT IDNCT04867369

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-08

Results submitted2024-11-14

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