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临床试验/CTRI/2018/07/014866
CTRI/2018/07/014866尚未招募不适用

Comparison of the postoperative analgesic efficacy of Levobupivacaine alone and with Dexamethasone in ultrasound guided Quadratus Lumbor

Dr SN Medical College and Attached group of Hospitals1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年7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
90
试验地点
1
主要终点
1. To compare the duration of analgesia.

研究概览

简要总结

This is a prospective randomised double blind study. Institutional ethical committee clearance obtained and informed consent would be taken from the patient. The total of 90 patients between the age 18 to 60 years of ASA grade 1 and 2 undergoing unilateral inguinal hernioplasty would be randomly divided into 2 groups of 45 each. After surgery under spinal anaesthesia, Group L will receive 0.25 % Levobupivane  20 ml + 1 ml 0.9 % normal saline and Group D will receive 0.25% 20 ml Levobupivacaine + 1 ml Dexamethasone (4 mg/ml) with a total of 21 ml in each group in ultrasound guided type 1 (lateral) Quadratus Lumborum block. Postoperatively, we will record and compare the duration of analgesia, total rescue analgesic (Tramadol) requirements and NRS pain scores in first 24 hours.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Age group of 18 –60 years of both sexes
  • ASA grade I and II
  • Weight 50-90 kg
  • Patients scheduled for elective unilateral inguinal hernia repair.

排除标准

  • Patient’s or relative’s refusal
  • Known hypersensitivity to local anesthetics
  • Opioid addict
  • Any chronic systemic illness
  • Bleeding diathesis
  • Severe stenotic heart diseases
  • Anatomical abnormality
  • Any infection at the regional site
  • Pregnant women
  • Pre existing peripheral neuropathy or neurological deficits.

结局指标

主要结局

1. To compare the duration of analgesia.

时间窗: 24 hours

2. To compare post operative rescue analgesic requirement in first 24 hours.

时间窗: 24 hours

3. Post-operative NRS ( Numerical Rating Scale ) scores.

时间窗: 24 hours

次要结局

  • 1. To compare the hemodynamic and respiratory parameters.(2. Any side effects or complications of study drugs and block.)

研究者

发起方
Dr SN Medical College and Attached group of Hospitals
申办方类型
Government medical college

研究点 (1)

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