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临床试验/NCT02724033
NCT02724033终止4 期

Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block With Intravenous Antiemetic Drugs Dexamethasone and Ondansetron and Incidence of Post-operative Nausea Vomiting for Inner Ear Surgery

Indiana University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
37
试验地点
1
主要终点
Evidence of Post Operative Nausea and Vomiting

研究概览

简要总结

The investigators would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck area an intervention known for analgesia but for which the antiemetic effects hasn't been entirely explored.

The rational is based on the knowledge of the anatomical innervation of the inner ear and the role of the parasympathetic nervous system in the emetic act. A lot of focus has been given on its counterpart the sympathetic nervous system and its role in painful conditions. The investigators believe that the nerve blockade of the parasympathetic innervation can have some beneficial effect in the post-surgical patient.

详细描述

The researchers hypothesize another potential antiemetic mechanism by the blockade of the auricular branch of the vagus nerve at the ear canal (commonly described as nerve of Arnold) in conjunction with a block of the greater auricular nerve and lesser occipital nerve at the superficial cervical plexus level. The block would cover both the sensory innervation and of the ear canal and the inner ear. A regional anesthetic block prior to the surgical intervention on the inner ear at the superficial cervical plexus block is performed. This latter is a branch of the vagus nerve at the superficial cervical plexus (erb's point). The block would inhibit the vagal afferent to area postrema through inhibition of afferent vagal input to the medullary center.

The emetic act (vomiting) is a highly integrated physiologic reflex involving both the somatic and autonomic nervous system. Researchers do not know how much of a relation there is between the vagal nerve branches involvement and incidence of nausea and vomiting effects are from the inner ear injury and or the inflammatory response type of response triggering the area postrema. The usual prophylactic treatment of PONV (post operative nausea and vomiting) has been limited to anti-emetics such as dexamethasone along with aggressive fluid therapy and adequate analgesia.

Investigators are proposing to conduct a comparative study of the therapeutic and cost effectiveness of regional anesthesia and antiemetic therapy in the prevention and treatment of PONV in children undergoing inner ear surgical procedures.

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
Single (Participant)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Age 1-18 yo
  • Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery
  • Past history of PONV susceptibility

排除标准

  • Patient/ Parents refusal
  • Infection at the site of local anesthetic injection
  • Known coagulopathy
  • Existing VP shunt
  • Severe mental disability
  • Any known allergic to dexamethasone (Decadron) and/or ondansetron ( Zofran)

研究组 & 干预措施

Group A

Active Comparator

Group A - regional nerve block

干预措施: regional nerve block (Procedure)

Group B

Active Comparator

Group B - antiemetic

干预措施: Antiemetic (Drug)

Group C

Active Comparator

Group C - block and antiemetic

干预措施: regional nerve block (Procedure)

Group C

Active Comparator

Group C - block and antiemetic

干预措施: Antiemetic (Drug)

结局指标

主要结局

Evidence of Post Operative Nausea and Vomiting

时间窗: Post Operative within 24 hour Follow up Period

number of patients with evidence of post operative nausea and vomiting

次要结局

未报告次要终点

研究者

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

Charles W. Yates

MD

Indiana University

研究点 (1)

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