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临床试验/CTRI/2025/10/096703
CTRI/2025/10/096703尚未招募3 期

Comparison of efficacy of two doses of dexmedetomidine as adjuvant to ropivacaine in ultrasound guided supraclavicular brachial plexus block: A Randomised Clinical Trail

Muhamed Shakeel1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Onset and duration of sensory and motor block (using hollmen scale and modified bromage scale)

研究概览

简要总结

Regional anaesthesia techniques have advantages including excellent pain control, side effects, and shortened stay in post anaesthesia care unit. Ultrasound guided regional blocks are considered safer with better success rates. Supraclavicular block has high efficacy for providing anaesthesia in upper limb surgeries. Ropivacaine with lesser cardiac side effects is the preferred local anaesthetic agent. Dexmedetomidine is used to reduce the onset time, prolong the analgesic and motor blockade effect without systemic side effects and reduce total dose of local anaesthetic requirement.

Here, in our study we determine the duration of analgesia and compare the hemodynamic parameters with two different doses of dexmedetomidine with 0.5% ropivcaine.

We also try to find any adverse reaction to the study drugs. A total of 60 patients undergoing upper limb surgeries will be divided into two groups - Group A and Group B by block randomisation. Group A will receive Ropivacaine 0.5% with 1ml of 0.5mcg/ kg dexmedetomidine and Group B will receive Ropivacaine 0.5% with 1ml of 1mcg/kg dexmedetomidine. Duration of analgesia, onset of sensory and motor blockade effect, time requirement of rescue analgesia will be studied.

Hemodynamic parameters and adverse effects will be recorded.

The findings and observations made during the entire study will be tabulated, graphically analysed and inference will be drawn.

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

  • American Society of Anaesthesiologist.
  • Physical State (ASA.
  • PS) grade I and II.

排除标准

  • Patients having hypertension, diabetes mellitus, neuropathy, perioheral nerve injury.
  • Pregnancy and lactation 3) Patient on anticoagulants or bleeding disorder.
  • Hypersensitivity to amide group of local anaesthetic agents.
  • Patient refusal to procedure.

结局指标

主要结局

Onset and duration of sensory and motor block (using hollmen scale and modified bromage scale)

时间窗: From injection of study drug till the time patient feels pain (sensory) and able to move upper limb (motor)

次要结局

  • Duration of analgesia(From injection of study drug till pain complains of pain)
  • Hemodynamic parameters like systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, peripheral oxygen saturation)(From injection of study drug to upto 2 hours.)

研究者

发起方
Muhamed Shakeel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Muhamed Shakeel

Regional Institutions of Medical Sciences

研究点 (1)

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