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临床试验/CTRI/2025/05/086460
CTRI/2025/05/086460尚未招募4 期

Effect of bilateral superficial cervical plexus block on postoperative analgesia in thyroid surgery under general anaesthesia Randomized controlled trial

Dr Neetu Kumari1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年5月20日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To assess the time of requirement of rescue analgesia in post operative period

研究概览

简要总结

Patients undergoing thyroid surgery will be randomly allocated in two groups are Group R and Group C.

GROUP R.25% 10 ml ropivacaine + .25mcg/kg dexmedetomidine on each side plus general anaesthesia

GROUP C only general  anaesthesia .

Written and informed consent from the patient will be taken.

Pre anaesthetic check-up will be done a day before surgery including detailed history, thorough physical examination and systemic examination. Age ,sex, body weight and ASA grading will be recorded.

Routine investigation- CBC, Thyroid profile , random blood sugar, serum urea, serum creatinine, coagulation profile will be checked on day of surgery.

Patient will be taken in operation theatre and all essential monitor will be attached such as ECG, NIBP, SPO2.

Two iv access of 18 G in both the hands will be obtained.

The patient will be premedicated with inj. Midazolam 0.02mg/kg followed by inj. fentanyl 2mcg/kg, preoxygenated for 3 minutes with 100% oxygen.

Induction will be done with inj. propofol (1.5mg/kg) and inj. Vecuronium .1mg/kg will be given for muscle paralysis and then after bag and mask ventilation of 3 minutes

patients trachea will be intubated with appropriate size of endotracheal tube.

Maintenance will be done by oxygen, nitrous oxide and sevoflurane with 1 MAC along with maintenance dose of Vecuronium.

Inhalational agent sevoflurane will be titrated during the course of surgery.

Subjects who will be randomized to

Group R will receive USG guided BSCPB with 10ml 0.25% Ropivacaine +. 25mcg/kg dexmedetomidine on both sides .

Group C will not receive any block

In order to ensure double blinding the doctor who will give the block and the doctor who

will record the parameter will be different and the doctor who record the parameter will not be present in operation theatre at the time of giving the block.

USG GUIDED:

Ultrasound guided BSCPB will be performed by using  sonosite  model of USG machine with 4 cm linear.

transducer with a frequency of 5-10 MHZ.

Then 20G needle will be attached toa 10cm iv extensor line for injecting the drug.

This nerve block will be performed in supine or semi- sitting position ,with head turned

slightly away from the side to be blocked to facilitate operator access

With the patient in proper position , the skin will be disinfected and transducer is placed on lateral neck, overlying SCM at the level of its midpoint.

The cervical plexus will be visible as a small collection of hypoechoic nodules (honeycomb appearance)immediately superficial to prevertebral fascia

Once the plexus has been identified, the needle will be passes through skin ,platysma and the investing layer of deep cervical fascia and the tip will be placed adjacent to plexus after negative aspiration of blood to exclude vascular puncture, drug will be injected.

We will observe heart rate and systolic blood pressure (SBP), diastolic blood pressure (DBP) mean arterial pressure (MAP) and End tidal carbon dioxide (ETCo2) during the

surgery at 5, 10, 15, 20, 25 ,30 ,35,40,45 at 50 minutes interval till the end of surgery.

Patients of all the groups will be observed every 2 hour for first 8 hour then after every 4 hourly till 24 hours of surgery for pain assessment. Visual Analogue Scale (VAS) will be used to access pain.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II Weight more than 30Kgs Age 18 to 65 years Patients with informed and written consent.

排除标准

  • Any local infection at the site of giving the block Known allergy to local anaesthetic agent.

结局指标

主要结局

To assess the time of requirement of rescue analgesia in post operative period

时间窗: Till 24 hour after end of surgery

次要结局

  • To evaluate the vital parameters NIBP SPO2 HR intraoperatively & postoperatively till the requirement of rescue analgesia

研究者

发起方
Dr Neetu Kumari
申办方类型
Other [self]

研究点 (1)

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