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临床试验/NCT03427502
NCT03427502已完成不适用

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial

Lumbini Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Postoperative agitation

研究概览

简要总结

Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS).

Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block.

Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing nasal surgery
  • Under General Anesthesia
  • With nasal packs

排除标准

  • Do not consent to the study.
  • History of allergy to lignocaine or bupivacaine

研究组 & 干预措施

Control Group

Placebo Comparator

At the end of surgery before nasal packing, scrub nurse will pass 10 ml of normal saline in a syringe to the surgeron.

Injection technique remains the same as in Study group.

干预措施: normal saline (Drug)

Study Group

Experimental

Experimental: Study Group At the end of surgery before nasal packing, scrub nurse will prepare 10 ml solution 0.5% bupivacaine with 1:2,00,000 adrenaline in a syringe and pass it over to the operating surgeon. The surgeon will block anterior ethmoidal nerve.

Injection technique: External nasal nerve will be blocked through an inter-cartilaginous injection into the dorsum of the nose.

Internal nasal nerve will be blocked in septum and lateral wall of nose. Septal block is done in upper anterior part of nasal septum. Three injections will be given on lateral nasal wall. First injection will be given just antero-superior to the attachment of middle turbinate (axilla). Second injection will be given at the anterior end of middle turbinate and third injection at the medial surface of middle turbinate. Withdrawal of injection will be done prior to deposition of solution every time to ensure that the solution is not deposited directly into a blood vessel.

干预措施: Bupivacaine-epinephrine (Drug)

结局指标

主要结局

Postoperative agitation

时间窗: 9:00 AM next morning

It will be assessed with Riker Sedation-Agitation Scale (SAS)

次要结局

未报告次要终点

研究者

发起方
Lumbini Medical College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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