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临床试验/NCT04930393
NCT04930393Unknown不适用

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

University of Southern California1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
74
试验地点
1
主要终点
Visual Analog Score at 6 hours following the block

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •medically optimized patients who will undergo an elective surgery for an arthroscopic rotator cuff repair with open biceps tenodesis

排除标准

  • •women who are pregnant or breastfeeding, history of chronic opioid use, respiratory compromise, smokers, or allergy to local anesthetics or opioids.

研究组 & 干预措施

PECS II Block

Active Comparator

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

干预措施: Nerve Block - either PECS II or axillary ring (Procedure)

Axillary Ring Block

Active Comparator

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.

干预措施: Nerve Block - either PECS II or axillary ring (Procedure)

结局指标

主要结局

Visual Analog Score at 6 hours following the block

时间窗: 6 hours post-block

次要结局

  • Morphine milligram equivalents (MME)(Right after surgery and 2 weeks)
  • Intraoperative Stimulation(2 hours during surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul S. Lee

Assistant Professor of Clinical Anesthesiology

University of Southern California

研究点 (1)

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