Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients

Study Overview
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Brief Summary
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Our current standard of care is to perform an interscalene peripheral nerve block for patients receiving rotator cuff repair surgery as it is an effective opioid-free alternative for post-operative pain control. However, many of these repairs require a supplemental incision for an open biceps tenodesis, which is not covered by the interscalene block. The intercostobrachial nerve covers this incision and is targeted by an axillary ring block or a single shot nerve block in the fascial plane between the pectoralis minor and serratus anterior muscles (otherwise termed as a PECS II block). This study will attempt to delineate if one is superior in postoperative analgesia and mitigating intraoperative stimulation by comparing an axillary ring block to a PECS II block. Patients receiving a rotator cuff repair with biceps tenodesis without histories of chronic opioid use and respiratory compromise will be eligible to be enrolled in the study. All patients will receive an interscalene block and group 1 will receive a supplemental axillary ring block and group 2 will instead receive a PECS II block. After surgery, the patients' pain score will be assessed upon PACU arrival, at 6 hours after block, and 2 weeks postoperatively. Their opioid requirements will also be assessed. Our primary outcome is pain score at 6 hours following the block.

Official Title
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A Randomized Double-blinded Study to Evaluate the Efficacy of PECS II Block Versus Intercostobrachial Ring Block in Patients Undergoing Arthroscopic Rotator Cuff Repair With Open Biceps Tenodesis

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Nerve Block - either PECS II or axillary ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medically optimized patients who will undergo an elective surgery for an arthroscopic rotator cuff repair with open biceps tenodesis Exclusion Criteria: women who are pregnant or breastfeeding, history of chronic opioid use, respiratory compromise, smokers, or allergy to local anesthetics or opioids.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PECS II Block<br>This group will receive an interscalene block in addition to a pectoral nerve block under ultrasound guidance with local anesthetic injected in the plane between the pectoralis minor and serratus anterior muscles | Procedure: Nerve Block - either PECS II or axillary ring<br>* In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis<br>|
| Active Comparator: Axillary Ring Block<br>This group will receive an interscalene block in addition to a ring block with local anesthetic injected subcutaneously along the axilla from anterior to posterior direction. | Procedure: Nerve Block - either PECS II or axillary ring<br>* In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score at 6 hours following the block |  | 6 hours post-block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine milligram equivalents (MME) | MMEs in recovery room after surgery and 2 weeks after surgery via phone call | Right after surgery and 2 weeks | 
| Intraoperative Stimulation | Whether patient displayed signs of pain (movement, elevated blood pressure or heart rate) under moderate sedation in the operating room | 2 hours during surgery |