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

Not Applicable

Recruiting

• Conditions: Shoulder Pain
• Interventions: Procedure: Nerve Block - either PECS II or axillary ring

• Registration Number: NCT04930393
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-18
• Study Start: 2021-09-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS II Block	Nerve Block - either PECS II or axillary ring	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
Axillary Ring Block	Nerve Block - either PECS II or axillary ring	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Score at 6 hours following the block	6 hours post-block

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Healthcare Center 3 - Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States