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临床试验/CTRI/2024/07/071614
CTRI/2024/07/071614已完成不适用

Comparison of the Analgesic Efficacy of Dexmedetomidine and Buprenorphine as adjuvant to 0.5 Percent Levobupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block in Patients Undergoing Upper Limb Surgeries-A Prospective Randomized Clinical Study

NIRANCHAN RAMANATHAN1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月18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
120
试验地点
1
主要终点
Assessment of Visual Analogue Scale (VAS) to calculate the duration of Pain relief. Rescue analgesia will be given when VAS score was more than or equal to 4.

研究概览

简要总结

The brachial plexus nerve block is a novel regional anaesthetic technique which is evolving and flourishing as an adjuvant and sometimes as an alternative to general anaesthesia. Brachial plexus provides a large part of sensory and motor innervation to upper limb, hence, blocking it is an effective method of providing anaesthesia from shoulder to finger tips. It has also been shown to be an attractive option, due to its effectiveness in terms of cost, along with benefit of postoperative analgesia. Several adjuvants can be added to the local anaesthetic to increase the quality and duration of the blockade. Levobupivacaine is an amino-amide long-acting local anaesthetic and the (S)-enantiomer of bupivacaine. It exerts its local anaesthetic effect by blocking voltage-gated sodium channels in the peripheral neurons. Dexmedetomidine a second generation α2 adrenergic receptor specific agent. The increased α2 selectivity results in more predictable and effective sedation and analgesia and fewer side effects. Buprenorphine is a semisynthetic opioid. It has the greater safety margin compared to other classical opioids. It blocks the Na+ channels by binding to the intracellular part of the receptor where the local anaesthetics bind. This study aims to find the analgesic efficacy of buprenorphine and dexmedetomidine as an adjuvant to 0.5% Levobupivacaine in ultrasound guided supraclavicular brachial plexus blocks.

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 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged between 18 to 65 years who are posted for Upper limb surgeries.

排除标准

  • 1.Patients who refuse to give informed written consent.
  • 2.Patients who are medically unstable.
  • 3.Patients with deranged coagulation profile.
  • 4.Patients who are addicted to narcotics.
  • 5.Patients who are allergic to levobupivacaine, ropivacaine, Dexmedetomidine.
  • 6.Pregnant women 7.Patients on opioid medications.
  • 8.Neurological and musculoskeletal disease.

结局指标

主要结局

Assessment of Visual Analogue Scale (VAS) to calculate the duration of Pain relief. Rescue analgesia will be given when VAS score was more than or equal to 4.

时间窗: Baseline Visual Analogue Score (VAS) is measured from the time patient is admitted at Postoperative ward and every 60 minutes for next 24 hours.

次要结局

  • To assess the Onset & Duration of sensory & motor blockade, intraoperative & intraoperative Hemodynamics & Sedation.

研究者

发起方
NIRANCHAN RAMANATHAN
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

NIRANCHAN RAMANATHAN

Tagore Medical College and Hospital

研究点 (1)

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