跳至主要内容
临床试验/CTRI/2025/03/082207
CTRI/2025/03/082207尚未招募不适用

Comparative evaluation of analgesic effect of ultrasound guided superficial cervial plexus block in mastoid surgeries.

Sanjay Gandhi Postgraduate Institute of medical sciences1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
试验地点
1
主要终点
Duration of analgesia which will be assessed by the time of the first dose of rescue analgesia needed after block placement if VAS score is greater than four at baseline and at 24 hours.

研究概览

简要总结

Mastoid surgeries are one of the commonest ear surgeries performed globally. Tradi8onally these surgeries are performed under general anaesthesia and have several issues like risk of post opera8ve pain and PONV. For pain management intraopera8vely and postopera8vely opioids are the mainstay, however opioids have their own problems like postopera8ve respiratory depression, hypoxia and nausea vomi8ng. With development of mul8modal analgesia, various blocks have been advocated for beDer post opera8ve pain management like SCPB. However, there are limited studies enumera8ng the effect of superficial cervical plexus block (SCPB) in mastoid surgeries. The limita8on of SCPB is dura8on of analgesia so various aDempts have been made to increase the dura8on by adding adjuvant medica8on. Dexamethasone is a popular adjuvant for peripheral nerve blocks but these studies are mostly related to brachial plexus blocks. There is one study of use of dexamethasone in SCPB in thyroid surgeries where it has shown beDer pain control in the post opera8ve period. But we could not find any study of SCPB in which dexamethasone has been used in mastoid surgery.

The primary objec8ve of the study is to observe the dura8on of analgesia which will be assessed by the 8me of the first dose of rescue analgesia if VAS score is greater than four. The secondary objec8ves will be to see the total analgesic consump8on, hemodynamic parameters intraopera8vely and postopera8vely and the incidence of post opera8ve nausea and vomi8ng (PONV). Following approval from the ins8tu8onal ethics commiDee and registering the trial at CTRI, a wriDen informed consent will be obtained from the pa8ents. The study will be done for a period of 18 months. Pa8ents will undergo preanaesthe8c checkup a night before surgery. General anaesthesia with endotracheal tube inser8on (midazolam/fentanyl/propofol/vecuronium) will be done. Pa8ents will be divided in two groups.

Group B- 8ml(0.25%) bupivacaine Group D-8ml(0.25%)bupivacaine +2ml normal saline +2ml dexamethasone

The pa8ent will be in supine posi8on with the ipsilateral shoulder on the side of block propped up and the head turned to contralateral side. The site of interest will be painted and draped with the superficial cervical plexus block being placed in all asep8c precau8ons with a high frequency linear ultrasound probe (5-13 MHz). At the end during skin suturing all pa8ents will receive i.v ondansetron and paracetamol 1gm i.v. The residual neuromuscular blockade will be reversed a_er the pa8ent is fully responsive and awake.The pa8ent will be then shi_ed to post opera8ve care unit (PACU) for observa8on and monitoring. All the pa8ents will receive i.v paracetamol 1g/8 hourly in the postopera8ve period. Rescue analgesic will be provided with diclofenac 75mg in 100ml normal saline slow I.V over 30 minutes if the VAS score is greater than 4. All pa8ents will be monitored for the first dose of rescue analgesia, total dose of rescue analgesia consump8on, nausea vomi8ng and adverse events in the post operative period.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA I and II patients.
  • Age between 18-70 years,
  • Both male and female patients.
  • Elective mastoid surgery under General Anaesthesia.

排除标准

  • Patient refusal
  • Altered neck anatomy (Previous neck surgeries etc.)
  • Previous ear surgeries
  • Seizure disorder
  • Diabetes mellitus
  • Pregnancy and lactating females
  • Motion sickness
  • Local site infection
  • Allergy to drugs
  • Substance abuse 11.

结局指标

主要结局

Duration of analgesia which will be assessed by the time of the first dose of rescue analgesia needed after block placement if VAS score is greater than four at baseline and at 24 hours.

时间窗: at baseline | at 24 hours after block

次要结局

  • 1. Total analgesic consumption(2. Hemodynamic parameters intraoperatively & postoperatively)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR Ashish Kumar Kannaujia

department of Anaesthesiology

研究点 (1)

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