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

February 27, 2024 updated by: Paul S. Lee, University of Southern California

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Healthcare Center 3 - Keck Hospital of USC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PECS II Block
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
In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis
Active Comparator: Axillary Ring Block
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
In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20-00980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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