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Clinical Trials/NCT04930393
NCT04930393
Recruiting
Not Applicable

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

University of Southern California1 site in 1 country74 target enrollmentSeptember 7, 2021
ConditionsShoulder Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
University of Southern California
Enrollment
74
Locations
1
Primary Endpoint
Visual Analog Score at 6 hours following the block
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2021
End Date
May 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul S. Lee

Assistant Professor of Clinical Anesthesiology

University of Southern California

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual Analog Score at 6 hours following the block

Time Frame: 6 hours post-block

Secondary Outcomes

  • Morphine milligram equivalents (MME)(Right after surgery and 2 weeks)
  • Intraoperative Stimulation(2 hours during surgery)

Study Sites (1)

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