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临床试验/CTRI/2025/08/092163
CTRI/2025/08/092163尚未招募2 期

Comparative Evaluation of Dexmeditomidine as an Adjuvant to 0.5% Ropivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgeries : A Randomized Double Blind Controlled Interventional Study

RNT Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To compare the duration of analgesia in the both groups.

研究概览

简要总结

The aim of giving anaesthesia to patients is performing safe and painless surgical and other medical procedures.

The upper extremity peripheral nerve blocks have been extensively used by anaesthetists for upper limb surgeries for decades. The peripheral nerve blocks have several benefits like better pain control, less undesirable side effects, and reduced hospital stay over general anaesthesia, thus providing a superior outcome. In peripheral nerve blocks, injection of the regional anaesthetic is given in the close vicinity of a specific nerve or bundle of nerves to block pain sensation generated and transmitted from a specific area of the body The local anaesthetic drugs block the transmission of pain signals from surgical site to the brain. Longacting local anaesthetic agents like bupivacaine and ropivacaine have been routinely used for upper limb surgeries in supraclavicular brachial plexus block. Ropivacaine is frequently used because it produces quick, dense, and prolonged block and has lesser side effects.

Due to the possibility of the effect of the local anaesthetic wearing out before the surgical period and causing severe pain, the volume of the local anaesthetic drug has been increased but it is associated with systemic side effects, particularly on the cardiovascular and nervous system. Therefore, several drugs such as opioids, nonsteroidal anti-inflammatory drugs NSAIDs, Alpha2-agonists, etc have been researched as adjunct agents to local anaesthetics. These are termed as analgesic

adjuvants. They increase the efficacy and duration of local anaesthetics and decrease the systemic side effects of a higher dose of local anaesthetic. However, the adjuvant itself may exhibit its own side effects such as hypotension, sedation, bradycardia, etc.

Dexmedetomidine is an Alpha 2 -adrenoreceptor agonist that has sedative, anxiolytic, and analgesic properties. Various studies have reported prolonged block and better postoperative analgesia with the administration of dexmedetomidine as an adjuvant to other local anaesthetics like bupivacaine or levobupivacaine.

However, there is very limited literature available on dexmedetomidine in combination with ropivacaine and the optimal dose of dexmedetomidine as an adjuvant in nerve blocks is still to be determined.

Furthermore, in clinical practice, none of the adjuvants is approved by the FDA. The use of such agents is completely off-label and depends on the assessment of risk to benefit ratio by the anaesthesiologists. Therefore, the debate regarding the advantages and disadvantages of using such an agents is a continuous topic discussion in the medical fraternity.

For this reason and with this background in mind, the present study will be designed with the aim for comparative evaluation of dexmedetomidine as an adjuvant to 0.5 percent ropivacaine in supraclavicular brachial plexus block for upper limb surgeries in terms of duration of analgesia, onset and duration of sensory and motor block, quality of block, duration of postoperative analgesia

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

  • 1.American Society of Anaesthesiologists physical status I-II 2.Upper limb surgeries below mid humerus level of duration 1-2 hours 3.Body Weight -40-70kgs 4.Subject Willing to Give Written and Informed Consent.

排除标准

  • 1.Uncooperative Patients.
  • Infection at the site of injection.
  • History of allergy to the study drugs.
  • Bleeding disorder and coagulopathies.
  • History of convulsions, severe neurological deficits.

结局指标

主要结局

To compare the duration of analgesia in the both groups.

时间窗: Duration of Analgesia is the time postoperatively when patient will demand for rescue analgesia or when patient NRS score is equal to or more then 4 in first 24 hours.

次要结局

  • To Study Onset sensory block in both groups.
  • To study onset of motor block in both groups.(Immediately after block in minutes)
  • To compare Duration of sensory in both groups.(Assessed postoperatively in first 24 hours)
  • To compare Duration of Motor block in both groups.(Assessed Postoperatively in first 24 hours)
  • To study Hemodynamic Response in both groups.(Assessed in first 24 hours after block.)
  • To study side effects and complications if any in both groups(Assessed in first 24 hours after block.)

研究者

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

Karan Swami

RNT Medical College Udaipur

研究点 (1)

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