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临床试验/NCT06042608
NCT06042608已完成不适用

Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
time spent in PACU (recovery room)

研究概览

简要总结

Interscalene blocks are frequently performed to decrease postoperative pain after shoulder surgeries and are considered the gold standard for pain control after this type of surgery. Some patients report pain in the axilla (armpit) following shoulder replacement surgeries. Sensation in the axilla is supplied by nerves not covered by the interscalene block. Sensation in the axilla can be decreased by performing an intercostobrachial nerve block. This study aims to study whether adding an intercostobrachial nerve block to the interscalene block decreases recovery room stay time, opioid pain medication requirement, and postoperative pain scores.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients 18-80 years old
  • Adult patient's BMI <= 35
  • Individuals presenting for primary total shoulder arthroplasty or reverse total shoulder arthroplasty
  • Anticipated discharge home same day of surgery
  • Patient is able to provide informed consent to participate in the study.

排除标准

  • Patient presenting for revision shoulder surgery
  • Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving liposomal formulation
  • Preexisting neurological deficits involving or potentially involving the ipsilateral brachial plexus
  • Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis
  • Psychiatric or cognitive disorders that could interfere with perioperative evaluation including drug or alcohol abuse
  • Chronic pain conditions
  • Preoperative opioid use
  • Moderate to severe pulmonary disease
  • Moderate to severe sleep apnea
  • Planned postoperative admission.
  • Unplanned postoperative admission
  • Any contraindication to interscalene or intercostobrachial nerve block including any local disorder of the skin where blockade is to be performed which would prevent safe performance of the block
  • Any coagulation abnormality which would be a contraindication for block placement
  • Preoperative chronic renal dysfunction requiring renal replacement therapy or CrCl < 60
  • Sulfa allergy (or other reason patient cannot receive celecoxib)
  • Allergy or intolerance to any medication in the protocol
  • Body mass index >35
  • Pregnancy
  • Incarceration
  • ASA classification greater than 3
  • Inability to provide informed consent
  • Refusal to participate in the study

结局指标

主要结局

time spent in PACU (recovery room)

时间窗: 0-2 hours after surgery

amount of opioid pain medications required to control postoperative pain

时间窗: 0-3 days after surgery

次要结局

  • pain scores (1-10 out of 10)(0-3 days after surgery)

研究者

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

Lisa Gu

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (2)

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