A study to compare the efficacy of ropivacaine alone and in combination with fentanyl or ketamine in modified pectoral block (PEC II) for analgesia following modified radical mastectomy (MRM)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.Intraoperative haemodynamic monitoring
研究概览
简要总结
The aim and objective of the thesis is to evaluate Whether ropivacaine alone or in combination with fentanyl or ketamine will be effective analgesics for modified pectoral block in patients following modified radical mastectomy Adult patients aged between 18-60 years of Female sex belonging to American Society of Anesthesiologists (ASA) physical status I-III undergoing breast surgery under general anaesthesia will be included in this study and we will asses Intraoperative haemodynamic monitorin,Postoperative haemodynamic monitoring,Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously),Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously),Diclofenac sodium & Tramadol consumption in surgical ward,VAS Score,Nausea score,Sedation score,Side effects observed a)Hypotension b)Bradycardia c) any other and Antiemetics required.Data will be copiled and appropriate stastical test will be done to analyse the result
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •All women aged between 20-60 years, belonging to American Society of Anesthesiologists (ASA) physical status I-III undergoing modified radical mastectomy (MRM) under general anaesthesia will be included in this study.
排除标准
- •Patients having contraindication to regional block, history of local anaesthetic allergy, psychiatric disorders, chronic opioid use, chachexic women and refusal to participate in the study will not been included.
结局指标
主要结局
1.Intraoperative haemodynamic monitoring
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
2.Postoperative haemodynamic monitoring
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously)
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously)
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
5.Diclofenac sodium & Tramadol consumption in surgical ward
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
6.VAS Score
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
7.Nausea score
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
8.Sedation score
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
9.Side effects observed a)Hypotension b)Bradycardia c) any other
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
10.Antiemetics required
时间窗: 1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
次要结局
- 1.Intraoperative haemodynamic monitoring(2.Postoperative haemodynamic monitoring)