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临床试验/CTRI/2020/06/025611
CTRI/2020/06/025611尚未招募Unknown

Comparison of efficacy of erector spinae plane block with paravertebral block for postoperative analgesia in patients undergoing breast cancer surgeries

Safdarjung hospital and Vardhman Mahavir Medical College New Delhi India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月6日最近更新:
适应症

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Duration of Analgesia- time from administration of the block till time of administration of first rescue analgesia to the patient will be noted (primary objective).

研究概览

简要总结

This study is aimed at comparing the efficacy of erectoe spinae plane block with paravertebral block for postoperative pain relief in patients undergoing breast cancer surgery.

Study will be conducted in adult females of age 18-60 years weighing>50 kgs fulfilling the criteria of  ASA physical status I and II undergoing breast cancer surgery under general anaesthesia with controlled ventilation.

Patient taken to O.T. and baseline parameters of HR, BP, SPO2 noted.

Standard general anaesthesia administered, inj dexamethasone 0.1mg/kg given, inj paracetamol 1gm i.v. over 30 mins administered.

Randomized into two groups:

GROUP E (USG guided erector spinae block) in lateral position using 21 ml of 0.5% ropivacaine + clonidine 1mcg/kg made to total of 22ml.

GROUP P(USG guided paravertebral block) in lateral position using 21ml of 0.5% ropivacaine +1 mcg/kg clonidine made to total of 22ml.

Intraoperative fentanyl requirement to be noted

Parameters to be noted after reversal:

1.Duration of analgesia

2.VAS score

3.Total tramadol requirement

4.PONV score

5.Patient satisfaction using NRS

6.Intraoperative fentanyl requirement

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • •This study will be conducted in adult female patients of age
  • •60 years weighing > 50 kgs, fulfilling criteria of American Society of Anaesthesiology (ASA) physical status i and ii undergoing elective modified radical mastectomy (MRM) for breast cancer under general anaesthesia with controlled ventilation.

排除标准

  • •coagulation disorder, local infection, allergy to study drugs
  • •anatomic deformity of spine or chest wall
  • •pregnant patient 4.morbid obesity
  • •liver or renalinsufficiency, respiratory/ cardiac/ psychiatric disease.

结局指标

主要结局

Duration of Analgesia- time from administration of the block till time of administration of first rescue analgesia to the patient will be noted (primary objective).

时间窗: Preoperative vitals to be noted at time 0. | Intraoperative vitals to be noted at before block, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 mins after the block. | postoperative: | 1. VAS assessment at 0,1,2,4,6.,12,24 hours | 2. PONV score assessed at 0,6,12,24 hours.

次要结局

  • 1) Visual Analogue Scale (VAS)(2) Total intraoperative requirement of fentanyl)

研究者

发起方
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi India
申办方类型
Government medical college

研究点 (1)

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