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临床试验/CTRI/2024/04/065232
CTRI/2024/04/065232尚未招募4 期

A Randomized comparative study of ultrasound guided superficial cervical plexus block versus local infiltration for post operative analgesia in modified radical mastoidectomy”

Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare Visual Analogue Score VAS postoperatively in both groups

研究概览

简要总结

Regional blocks such as Superficial cervical plexus block (SCPB) and Local infiltration are both techniques used in post operative patients undergoing Modified Radical Mastoidectomy(MRM) surgery to reduce postoperative pain.

After getting approval from Institutional Ethical Committee (IEC) ,those patients who are fit in inclusion criteria will be included in our study

Randomization using computer generated random number which are sealed in opaque envelop will be done.

General anaesthesia will be given as per the institution’s protocol.

After surgery before extubation, SCPB and Local infiltration will be perfomed under the gudiance of ultrasound machine (Sonosite MicroMaxx P08840-22)with

5-10Hz linear probe using 5cm echogenic needle

Group S-Ultrasound guided SCPB, 5ml Ropivacaine 0.5%

Group L- Local infiltration, 5ml Ropivacaine 0.5%

The patient will be shifted to PACU and standard analgesia (1 gm PCM 8 hrly i/v) will be given as per standard institute protocol.

VAS score and haemodynamic parameter will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.

VAS >4 will be given rescue analgesia in form of I/V diclofenac 75mg. Total rescue analgesic consumption

in 24 hrs and complications will be noted.

Data will be analyzed using the appropriate statistical method.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patient under going modified radical mastoidectomy Informed and written consent ASA physical status I-II.

排除标准

  • H/o Motion sickness H/o of seizures, malignancy Allergy to local anaesthesia.

结局指标

主要结局

To compare Visual Analogue Score VAS postoperatively in both groups

时间窗: VAS score will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.

次要结局

  • To compare time for first rescue analgesia in both groups.(To compare total consumption of analgesics in first 24 hours in both groups)

研究者

发起方
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Trapti Singh

Teerthanker Medical College and Research Centre , Moradabad

研究点 (1)

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