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临床试验/CTRI/2023/06/053543
CTRI/2023/06/053543尚未招募不适用

Analgesic Efficacy of Erector Spinae Block versus Quadratus Lumborum III Block in patients undergoing Unilateral Percutaneous Nephrolithotomy Surgery under General Anesthesia

Dr Pooja Singh1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年6月15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
78
试验地点
1
主要终点
To determine and compare postoperative pain relief using the numeric rating scale (NRS) score between the group E and group Q

研究概览

简要总结

This is a prospective observational study to be conducted on total of 78 patients of age between 18 to 65 years of either sex belonging to ASA grade I,II and III undergoing elective unilateral percutaneous nephrolithotomy surgery under general anaesthesia in All  India Institute of Medical Sciences, Bhopal after undergoing routine investigations and  pre anesthetic check up .An informed written consent will be obtained from patient and legally acceptable witness.Patient  will be randomly allocated to either group  E, receiving Erector spinae plane block :ESPB or group Q receiving quadratus lumbarm block III :QLB III through computer based allocater . In operation theatre all standard ASA monitoring will be attached and baseline vitals will be recorded including blood pressure ,ECG ,SpO2 , temperature. After induction of general anaesthesia and securing airway ,patient will be positioned according to block i .e. lateral position for QLB III and prone position for ESPB . Block will be performed after satisfactory placement of needle under ultrasound guidance and confirming by injecting 1- 2 ml of saline ,once confirmed 20 ml of inj. BUPIVACAINE 0.25% will be injected. Intraoperative hemodynamic monitoring will be done and Inj FENTANYL 1-2 mcg/kg  will be given if heart rate or blood pressure or both increases more than 20% of baseline. After the completion of surgery ,complete recovery from nesthesia and achieving adequate level of consciousness patient will be shifted to postoperative recovery room. Hemodynamic parameters will be monitored for 1 hour and patient will be shifted to ward .NRS scores will be assessed at interval of 1,2,6, 12 and 24 hours postoperative at rest and during activity. If NRS score is >= 3 injection paracetamol 1 gram will be given as rescue drug. If pain  persists then injection tramadol 50 mg slow i.v. infusion will be given as second analgesia . NRS scores will be furthers according to timeline and total total dose  of tramadol is calculated over 24 hours.Post operative complications will also be monitored.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Study will include patients between 18 to 65years of either sex with ASA physical status 1 to 3 planned for elective percutaneous nephrolithotomy.

排除标准

  • Patient’s refusal to the procedure.
  • Contraindications to regional technique e.g., allergy to local anesthetic drugs, infection around site of block, any coagulation disorder, sepsis Body mass index > 35kg/m2 Pregnancy Physical or mental disorders that would interfere with evaluation of pain.

结局指标

主要结局

To determine and compare postoperative pain relief using the numeric rating scale (NRS) score between the group E and group Q

时间窗: At 1 hour, 2 hours, 6 hours, 12 hours and 24 hours postoperatively at rest and during activity

次要结局

  • 1.To determine & compare the time of the first analgesic.(2.To determine and compare the total perioperative opioid consumption in 24 hours)

研究者

发起方
Dr Pooja Singh
申办方类型
Other [self]

研究点 (1)

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