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
About this trial
This is an interventional prevention trial for Shoulder Pain
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.
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
NCT ID
NCT04930393
First Posted
April 28, 2021
Last Updated
June 15, 2021
Sponsor
University of Southern California
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
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Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients
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