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临床试验/NCT07241364
NCT07241364进行中(未招募)不适用

Effect of the Superficial Cervical Plexus Block in the Hypotensive Anesthesia of Ear Surgery.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 46 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
进行中(未招募)
入组人数
46
试验地点
1
主要终点
pain

研究概览

简要总结

We aimed to evaluate the analgesic effect of ultrasound guided Superficial cervical plexux block in tympanomastoid ear surgeries by comparing it with conventional general anaesthesia using systemic analgesic through observation of intra- and postoperative requirements of the total dose of systemic analgesics, visual analog scale (VAS) score, total duration of analgesia, vital parameters and the occurrence of any perioperative complications.

详细描述

Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, General anaesthesia (GA) will be induced with intravenous inj. of propofol 2-2.5 mg/kg, , fentanyl 1 microgram/kilogram (μg/kg). and atracuruim 0.5 mg/kg was given for muscle relaxation .

In study Group patients, superficial CPB will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance .

Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle. [2].

General anaesthesia will maintained with O2 + air (50:50), 3-litre flow, sevoflurane 2% to 2.5% and an intravenous inj. of atracuiruim 0.01 mg/kg every 20 min. An intraoperative rise in heart rate (>100/min) and systolic blood pressure (≥ 20% from pre-induction value) will be recorded and managed by giving intravenous inj. of fentanyl 0.5 microgram/kg in incremental doses (dose of fentanyl did not exceed 3 μg/kg for less than three hours of surgery). At the end of the surgery, the reversal of residual neuromuscular block will be done and the patient will be extubated. The patient will be then transferred to the recovery room and the severity of pain will be assessed by a VAS scale ( visual analog score scale ), which is a straight line denoting one end with no pain and the other end with the worst pain. VAS score was calculated as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; 10, worst pain. The VAS score will be assessed when the patient could follow verbal commands.

Evaluation of block for adequate analgesia intraoperatively will be done in terms of the total requirement of intravenous analgesics through the observation of heart rate and blood pressure and postoperatively, it will be done by observing VAS score, time of first demand for a bolus of rescue analgesic (intravenous paracetamol) and total requirement of rescue analgesic in 24 hours.. Pulse, mean blood pressure (BP), oxygen saturation (SpO2) and any side effects were also noted.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1 - Both genders. 2- Age between 20 -40 years. 3- ASA 1 & 2 physical status. 4- Patients undergoing simple ear surgery as Tympano-mastoidectomy

排除标准

  • 1- Infection at or near the injection site. 2- Uncontrolled preoperative hypertension. 3- age < 20 or >40 4- chronic opoid abuse patients. 5- patients with pre existing neuropathy or other neurological diseases. 6- patients on anticoagulation. 7- plt count < 100 or INR > 1.7 8- lengthy surgery more than 3 hours . 9- hypersensitivity to local anesthetics. 10- patients with psychiatric illness.

结局指标

主要结局

pain

时间窗: 24 hours

monitoring pain score using visual analog score (VAS) postoperative . to evaluate the analgesic effect

analgesia

时间窗: 24 hours

The number of analgesic doses required for each patient as rescue analgesia (when VAS \> 3), will be recorded and statistically compared between the two groups

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

Lydia edward aziz zakhary

lecturer of anesthesia , intensive care and pain management

Ain Shams University

研究点 (1)

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