跳至主要内容
临床试验/NCT04138147
NCT04138147Unknown不适用

Efficacy of Superficial Cervical Plexus Block Versus Cervical Retrolaminar Block Both Combined With Auriculotemporal Nerve Block in Parotid Surgeries

Mansoura University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
28
试验地点
2
主要终点
The time of first analgesic request post-operative.

研究概览

简要总结

The parotid gland receives sensory and autonomic innervation. Sensory innervation is supplied by the auriculotemporal nerve (gland) and the great auricular nerve (fascia). The parasympathetic innervation to the parotid gland begins with the glossopharyngeal nerve. This nerve synapses with the otic ganglion. The auriculotemporal nerve then carries parasympathetic fibers from the otic ganglion to the parotid gland. Parasympathetic stimulation increase saliva production. Sympathetic innervation from the superior cervical ganglion, part of the paravertebral chain

详细描述

Detailed Description:

The aim of this study will be comparing efficacy of superficial cervical plexus block with cervical retro laminar block both combined with auriculotemporal nerve block in parotid surgeries.

Technique of ultrasound guided auriculotemporal nerve block:

The patient will be placed in a supine position with each side facing up. The temporomandibular joint will be identified after palpitation. A high frequency linear ultrasound transducer (7-12 megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300, Germany) will be placed between the tragus and temporomandibular joint. Color Doppler imaging will be used to identify the superficial temporal artery. The injection needle will be inserted anterior to the tragus posterior to the temporal artery (out-of-plane approach) 1 to 1.5 cm till reaching the periosteum. The reason of out-of-plane approach is that the superficial temporal artery is in the needle entry of in-plane procedure during auriculo-temporal nerve block. Following negative aspiration local anesthetic will be injected in fractionated doses following intermittent aspiration.

Technique of ultrasound guided superficial cervical plexus block:

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status grade I and grade II.
  • Elective parotid surgery.

排除标准

  • Patient refusal.
  • Coagulopathy.
  • Psychiatric diseases.
  • Local skin infection and sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m
  • Central or peripheral neurological disease.
  • Previous neck surgery.

结局指标

主要结局

The time of first analgesic request post-operative.

时间窗: 24 hours postoperative.

The time of first analgesic request in hours.

次要结局

  • Assessment of diaphragmatic dysfunction.(1 hour postoperative.)
  • Mean arterial blood pressure (MAP).(Intraoperative (2 hours), postoperative for 24 hours.)
  • Total post-operative opioid requirement.(24 hours postoperative.)
  • The number of patients required rescue post-operative opioid analgesia..(24 hours postoperative.)
  • The concentration of isoflurane.(Intraoperative (2 hours).)
  • Heart rate (HR).(Intraoperative (2 hours), postoperative for 24 hours.)
  • The block procedural duration.(30 minutes.)
  • Post-operative complication rate (nausea, vomiting and headache)(24 hours postoperative.)
  • Post-operative pain scale.(24 hours postoperative.)
  • Intra-operative fentanyl consumption.(Intraoperative (2 hours).)
  • Intra-operative atracurium consumption(Intraoperative (2 hours).)
  • Sensory block assessment.(1 hour post-operative.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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