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.
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
Dr Koushikee Chandra
Burdwan Medical College and Hospital
