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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04930393
Enrollment
74
Registered
2021-06-18
Start date
2021-09-07
Completion date
2024-05-31
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

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.

Interventions

PROCEDURENerve 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

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Visual Analog Score at 6 hours following the block6 hours post-block

Secondary

MeasureTime frameDescription
Morphine milligram equivalents (MME)Right after surgery and 2 weeksMMEs in recovery room after surgery and 2 weeks after surgery via phone call
Intraoperative Stimulation2 hours during surgeryWhether patient displayed signs of pain (movement, elevated blood pressure or heart rate) under moderate sedation in the operating room

Countries

United States

Contacts

Primary ContactPaul Lee, MD
pauls.lee@med.usc.edu4109132126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026