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临床试验/NCT02733393
NCT02733393已完成1 期

Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy- An Open Label Pilot Study

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
2
试验地点
1
主要终点
Shoulder Pain Reduction

研究概览

简要总结

The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.

详细描述

This is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP). It will determine if SPG block has potential utility to manage ISP in post-thoracotomy patients One hundred (100) patients will initially be consented in this study. Patients have to develop ISP and have a pain VAS >= 5. The study is seeking ten (10) eligible participants.

Patients will be followed after the SPG block(s), and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed. The follow-up assessments will only involve having the patient rate the ISP using a verbal VAS; This will take less than a minute of patients time. In addition, all patients will have PRN access to standard systemic analgesics as routinely ordered by the surgical service Safety assessments will be performed on all subjects. Blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each SPG block for 90 minutes. Dr. Grant will monitor the subjects for 90 minutes after each SPG block.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Any type of open thoracotomy or video-assisted thoracoscopic surgery (VATS)
  • Presence of post-operative ISP, VAS>5/10
  • American Society of Anesthesiologists Class 1 - 4
  • No allergy to lidocaine

排除标准

  • American Society of Anesthesiologists Class 5
  • Allergy to lidocaine
  • Nasal pathology (e.g., deviated septum)
  • Bleeding diathesis
  • Any patient who the PI feels will be unable to comply with all protocol related procedures
  • Shoulder pain prior to thoracotomy

研究组 & 干预措施

SPG Block

Experimental

干预措施: Sphenopalatine Ganglion (SPG) Block (Procedure)

SPG Block

Experimental

干预措施: lidocaine (Drug)

结局指标

主要结局

Shoulder Pain Reduction

时间窗: 90 Minutes

Patients will be followed after the SPG block(s) and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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