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临床试验/CTRI/2025/10/096234
CTRI/2025/10/096234招募中不适用

A comparative study between Dexmedetomidine and Clonidine as adjuvant with Ropivacaine in ultrasound guided erector spinae block for post operative analgesia in modified radical mastectomy.

Dr Koushikee Chandra1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Visual analog scale for pain score

研究概览

简要总结

Summary:

Breast cancer surgeries are increasingly performed but adequate postoperative analgesia is often

not achieved leading to complications and worsened quality of life. Erector Spinae Plane Block

using ropivacaine has emerged as a promising regional anaesthesia technique that can

effectively control pain and offers lesser complications than their alternate available modalities.

Alpha2 adrenergic agonists like clonidine and dexmedetomidine are used as adjuvants in peripheral

nerve blocks to increase the duration of analgesia for effective control of pain. Very few studies

have been done to compare their efficacy in ESPB. Hence this study is proposed to explore their

differences.

OBJECTIVE OF PROPOSED RESEARCH

To compare the duration of analgesia between dexmedetomidine and clonidine as an adjuvant in

ultrasound guided Erector Spinae Plane Block using Ropivacaine.

METHODOLOGY

After getting approval of the Institutional Ethics Committee, patient recruitment will be done.

Selection of patients base on the inclusion and exclusion criteria will be followed by proper

counselling and informed consent will be taken. Patients will be divided by sequential sampling in

either of two groups, RC and RD; according to the adjuvant clonidine or dexmedetomidine use.

Preoperative US-guided ESPB will be done and in the postoperative period the duration of

analgesia, level of sedation and hemodynamic parameters will be measured.

EXPECTED OUTCOME

At the end of this study, we will find out if there is any significant difference between

dexmedetomidine and clonidine in their ability to increase the duration of analgesia when used as an

adjunct to ropivacaine in erector spinae plane block.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I II or III BMI less than 30 kg per square meter Modified radical mastectomy surgery.

排除标准

  • ASA physical status IV Patient refusal Patients with untreated COPD DM Bronchial asthma obstructive sleep apnoea uncontrolled hypertension Patients with known hypersensitivity to study drugs Patients with coagulation disorder.

结局指标

主要结局

Visual analog scale for pain score

时间窗: at 0 hrs (base line) 3,6,9,12,15,18,21 and 24 hrs

次要结局

  • Ramsay sedation scale score(Mean arterial pressure)

研究者

发起方
Dr Koushikee Chandra
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Koushikee Chandra

Burdwan Medical College and Hospital

研究点 (1)

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