跳至主要内容
临床试验/CTRI/2018/07/014747
CTRI/2018/07/014747尚未招募不适用

Evaluation of analgesic effect of magnesium sulphate as an adjuvant to ropivacaine in pectoral nerve block.

Dr Harmanpreet Kaur Jhand1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of:

研究概览

简要总结

Introduction: The pectoral nerve (PECS) block, first described by Blanco et al., is an interfascial plane block. It is a safe and inexpensive technique with the advantages of providing ideal operating conditions and effective post-operative analgesia.

The study will be conducted in a randomized manner in the Department of Anaesthesiology, G.G.S. Medical College and Hospital, Faridkot on 60 adult female patients of age between 18 to 65 years, American Society of Anaesthesiologists’ (ASA) Grade I and II, scheduled to undergo modified radical mastectomy under general anaesthesia (GA) with pectoral nerve block. The patients will be randomly allocated into 2 groups of 30 patients each.

Group A: Patients will receive 30 ml of drug volume of 0.25% ropivacaine with 10 ml of normal saline as placebo.

Group B: Patients will receive 30 ml of drug volume of 0.25% ropivacaine with 150 mg of magnesium sulphate diluted to 10 ml of normal saline.

Duration of post-operative analgesia, total analgesic consumption in 24 hours post-operatively, patient satisfaction score and side effects will be assessed in both the groups. The data will then be statistically analyzed.

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
Female

入选标准

  • American Society of Anaesthesiologists’ Grade I and II patients.
  • Patients of age between 18 to 65 years, undergoing modified radical mastectomy (MRM) surgery under general anaesthesia (GA).Patients willing to give informed written consent.

排除标准

  • Patients with any contraindication to regional anesthesia or history of anaphylaxis to local anaesthetics or allergy to the study drugs.ASA-III & ASA-IV patients.
  • Pregnant or lactating patients.
  • Patient’s refusal for Pectoral nerve block.

结局指标

主要结局

To evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of:

时间窗: To evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of: | Duration of post-operative analgesia. | Total analgesic consumption in 24 hours post-operatively.

Duration of post-operative analgesia.

时间窗: To evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of: | Duration of post-operative analgesia. | Total analgesic consumption in 24 hours post-operatively.

Total analgesic consumption in 24 hours post-operatively.

时间窗: To evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of: | Duration of post-operative analgesia. | Total analgesic consumption in 24 hours post-operatively.

次要结局

  • To record any side effects and patient satisfaction score(Side effects)

研究者

发起方
Dr Harmanpreet Kaur Jhand
申办方类型
Other []

研究点 (1)

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