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临床试验/CTRI/2024/09/073782
CTRI/2024/09/073782尚未招募Phase 3 4

Comparison between sodium bicarbonate and dexamethasone as adjuncts to levobupivacaine for post operative analgesia, given via ultrasound guided lateral quadratus lumborum block for hip surgery.

Uttar Pradesh University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.Duration of analgesia.

研究概览

简要总结

The ideal peripheral nerve block technique for hip arthroplasty should achieve adequate sensory block without affecting motor function. The sensory afferent of the hip joint arise from several branches of lumbar plexus. Ultrasound guided quadratus lumborum block has been described as an analgesic technique in abdominal surgeries as well as in various lower limb surgeries (lateral or posterior QL block). It is performed through the injection of a local anaesthetic mixture between the lateral abdominal layers and QL muscle. The peculiar feature of this block is that it not only sensory nerves but also the visceral nerves. Peripheral nerve blocks provide longer and localized pain relief with early ambulation and also avoid the side effects of systemic medication. The major limiting factor with the use of local anaesthetic are their short duration of action and delayed onset. To overcome these shortcomings, adjuvant such as opioids, magnesium, ketamine etc have been used. In this study we will compare the duration of analgesia with two adjuvants dexamethasone and sodium bicarbonate with levobupivacaine.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA physical status 1 and
  • Elective hip surgery under subarachnoid block.

排除标准

  • Patients with a history of allergy to drugs used in the study .
  • Any history of substance abuse .
  • Body mass index (BMI) ≥30 .
  • Patients with psychosis/gross neurological disorders.

结局指标

主要结局

1.Duration of analgesia.

时间窗: 1.After the block is give we will note the very first time when VAS4 and measure the VAS score at an interval of 4 hours till 24 hours. | 2.After the 24 hours from the time block is given we will see the satisfaction score.

2.Quality of analgesia.

时间窗: 1.After the block is give we will note the very first time when VAS4 and measure the VAS score at an interval of 4 hours till 24 hours. | 2.After the 24 hours from the time block is given we will see the satisfaction score.

次要结局

  • 1.Hemodynamic parameters.(2.Total need for rescue analgesia over 24 hours.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mehak Gupta

UPUMS, Saifai, Etawah

研究点 (1)

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