Clinical trial NCT04930393: 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
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Visual Analog Score at 6 hours following the block
timeFrame: 6 hours post-block
Secondary outcomes:
measure: Morphine milligram equivalents (MME)
timeFrame: Right after surgery and 2 weeks
measure: Intraoperative Stimulation
timeFrame: 2 hours during surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Healthcare Center 3 - Keck Hospital of USC
state: California
Study officials:
References:
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