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

NCT ID: NCT04930393

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2024-05-31

Brief Summary

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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

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Patient and Provider won't be aware of what block will be administered until just before the nerve block is done

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Nerve Block - either PECS II or axillary ring

Intervention Type PROCEDURE

In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis

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.

Group Type ACTIVE_COMPARATOR

Nerve Block - either PECS II or axillary ring

Intervention Type PROCEDURE

In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Paul S. Lee

Assistant Professor of Clinical Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Healthcare Center 3 - Keck Hospital of USC

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Lee, MD

Role: CONTACT

4109132126

Facility Contacts

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Paul Lee, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23108685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27988164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21831090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22939099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27543533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31572077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30957884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31136331 (View on PubMed)

Other Identifiers

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HS-20-00980

Identifier Type: -

Identifier Source: org_study_id

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