Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Study Overview
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Brief Summary
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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.

Official Title
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Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Conditions
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Tendonitis

Intervention / Treatment
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* Drug: Pecs II block
* Drug: Surgical infiltration


Participation Criteria
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Eligibility Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pecs II block<br>80 patients scheduled for open biceps tenodesis | Drug: Pecs II block<br>* Patients will receive an interscalene nerve block with 15 mL 0.5% bupivacaine + a Pecs II fascial plane block with 20 mL 0.25% bupivacaine<br>|
| Active Comparator: Surgical infiltration<br>80 patients scheduled for open biceps tenodesis | Drug: Surgical infiltration<br>* Patients will receive an interscalene nerve block with 20 mL 0.5% bupivacaine + local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oxycodone equivalent |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported Visual Analog Scale (VAS) scores in PACU | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. | 24 hours | 
| Patient reported Visual Analog Scale (VAS) score at postoperative day 1 (POD 1) | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. | 24-48 hours | 
| Patient reported Visual Analog Scale (VAS) score at postoperative day 3 (POD 3) | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. | 72 hours | 
| Incidence of patient reaction to surgical subpectoral incision | signs include patient movement, tachycardia, etc. | 24 hours | 
| Presence or absence of sensation to cold and pinprick in PACU | Alcohol 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. | 24 hours |