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临床试验/CTRI/2024/11/077503
CTRI/2024/11/077503已完成不适用

Comparison Of 0.25mcg/kg Dexmedetomidine and 0.5mcg/kg Dexmedetomidine as an Adjuvant to 0.2% Ropivacaine For Postoperative Analgesia in Ultrasound Guided Transversus Abdominis Plane Block for Open Inguinal Hernia Repair – A Randomized Controlled Trial

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年12月11日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Comparison of dexmedetomidine 0.25mcg/kg and 0.5 mcg/kg as

研究概览

简要总结

• Regional anesthetic offers site-specific, long-lasting, and effective anesthesia. Transversus abdominis plane block is a peripheral nerve block that blocks feeling in the parietal peritoneum and the anterior and lateral abdominal walls..

• Transversus abdominis plane contains intercostal nerves (T7-T11), subcostal nerves(T12), iliohypogastric and ilioinguinal nerves(L1).

•Due to its accessibility, dependability, and safety, it is one of the most often used truncal blocks for post-operative analgesia in lower abdominal procedures. • The amount of local anesthetic used, the frequency of vascular punctures, and the block performance time are all decreased using ultrasound guiding.

• Chronic or persistent postoperative pain results from acute postoperative pain that is not well managed. Between 5% and 35% of hernia repair cases involve chronic pain (3). • The addition of adjuvant increases the effectiveness of local anesthetics by decreasing the duration of onset of action, prolonging the duration of action, decreasing pain intensity, reducing consumption of systemic opioids, and reducing systemic side effects. • Ropivacaine, an enantiomer of buprevacaine, is a long-acting amide that is less likely to penetrate large myelinated motor fibers, resulting in a safer cardiac profile used for peripheral nerve block.

• Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist with analgesic and sedative properties. It prolongs the duration of both sensory and motor blockade induced by local anaesthetics when

administrated by epidural, caudal, or spinal route.

• There are certain studies using 1mcg/kg or 0.5mcg/kg of dexmedetomidine as an adjuvant to local anaesthetic agent in TAP block, therefore in order to observe the analgesic efficacy and side effects of using further lower dose of dexmedetomidine, 0.25mcg/kg will be taken.

• Hence, the aim of this study is to compare 0.25mcg/kg

Dexmedetomidine and 0.5mcg/kg dexmedetomidine as an adjuvant to 0.2% ropivacaine in ultrasound guided transversus abdominis plane block for post operative analgesia in open inguinal hernia repair.

研究设计

研究类型
Interventional
分配方式
Other
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

  • Patient scheduled for elective open Inguinal hernia surgery under subarachnoid block.
  • American society of Anesthesiologist (ASA) physical status I, II.
  • Patient giving consent for study.
  • BMI less than 30 kg/m2.

排除标准

  • Bleeding disorders.
  • History of cardiac, renal, respiratory or hepatic disease.
  • Allergy to study drugs.
  • Patients consuming adrenoceptors agonist or antagonist.

结局指标

主要结局

Comparison of dexmedetomidine 0.25mcg/kg and 0.5 mcg/kg as

时间窗: 1) Numerical rating scale (NRS) for pain assessment at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia in 24 hrs. | 3) Total analgesic doses required in first 24 hours.

an adjuvant to 0.2% ropivacaine for post operative analgesia in

时间窗: 1) Numerical rating scale (NRS) for pain assessment at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia in 24 hrs. | 3) Total analgesic doses required in first 24 hours.

ultrasound guided transversus abdominis plane block in open

时间窗: 1) Numerical rating scale (NRS) for pain assessment at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia in 24 hrs. | 3) Total analgesic doses required in first 24 hours.

inguinal hernia repair

时间窗: 1) Numerical rating scale (NRS) for pain assessment at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia in 24 hrs. | 3) Total analgesic doses required in first 24 hours.

次要结局

  • To compare side effects of dexmedetomidine 0.25mcg/kg and(0.5mcg/kg as an adjuvant to 0.2% ropivacaine in ultrasound guided)

研究者

发起方
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Kalyani Thote

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital

研究点 (1)

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