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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nerve Block - either PECS II or axillary ring
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    PECS II Block

    Axillary Ring Block

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Visual Analog Score at 6 hours following the block

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 28, 2021
    Last Updated
    June 15, 2021
    Sponsor
    University of Southern California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04930393
    Brief Title
    Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern California

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Patient and Provider won't be aware of what block will be administered until just before the nerve block is done
    Allocation
    Randomized
    Enrollment
    74 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PECS II Block
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Axillary Ring Block
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Nerve Block - either PECS II or axillary ring
    Intervention Description
    In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis
    Primary Outcome Measure Information:
    Title
    Visual Analog Score at 6 hours following the block
    Time Frame
    6 hours post-block
    Secondary Outcome Measure Information:
    Title
    Morphine milligram equivalents (MME)
    Description
    MMEs in recovery room after surgery and 2 weeks after surgery via phone call
    Time Frame
    Right after surgery and 2 weeks
    Title
    Intraoperative Stimulation
    Description
    Whether patient displayed signs of pain (movement, elevated blood pressure or heart rate) under moderate sedation in the operating room
    Time Frame
    2 hours during surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul Lee, MD
    Phone
    4109132126
    Email
    pauls.lee@med.usc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23108685
    Citation
    Cho CH, Song KS, Min BW, Jung GH, Lee YK, Shin HK. Efficacy of interscalene block combined with multimodal pain control for postoperative analgesia after rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):542-7. doi: 10.1007/s00167-012-2272-3. Epub 2012 Oct 30.
    Results Reference
    background
    PubMed Identifier
    27988164
    Citation
    Liu XN, Noh YM, Yang CJ, Kim JU, Chung MH, Noh KC. Effects of a Single-Dose Interscalene Block on Pain and Stress Biomarkers in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2017 May;33(5):918-926. doi: 10.1016/j.arthro.2016.09.018. Epub 2016 Dec 14.
    Results Reference
    background
    PubMed Identifier
    21831090
    Citation
    Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22939099
    Citation
    Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
    Results Reference
    background
    PubMed Identifier
    27543533
    Citation
    Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
    Results Reference
    background
    PubMed Identifier
    31572077
    Citation
    Siddeshwara A, Singariya G, Kamal M, Kumari K, Seervi S, Kumar R. Comparison of efficacy of ultrasound-guided pectoral nerve block versus thoracic paravertebral block using levobupivacaine and dexamethasone for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):325-331. doi: 10.4103/sja.SJA_25_19.
    Results Reference
    background
    PubMed Identifier
    30957884
    Citation
    Versyck B, van Geffen GJ, Chin KJ. Analgesic efficacy of the Pecs II block: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):663-673. doi: 10.1111/anae.14607.
    Results Reference
    background
    PubMed Identifier
    31136331
    Citation
    Reynolds JW, Henshaw DS, Jaffe JD, Dobson SW, Edwards CJ, Turner JD, Weller RS, Graves BR, Freehill MT. Analgesic Benefit of Pectoral Nerve Block II Blockade for Open Subpectoral Biceps Tenodesis: A Randomized, Prospective, Double-Blinded, Controlled Trial. Anesth Analg. 2019 Aug;129(2):536-542. doi: 10.1213/ANE.0000000000004233.
    Results Reference
    background

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

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