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临床试验/CTRI/2025/02/081248
CTRI/2025/02/081248已完成4 期

Comparison Of Dexmedetomidine And Dexamethasone As An Adjuvant To Ropivacaine 0.5 Percentage In Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries: A Randomised Clinical Trial

Arivumadhi Sankar1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年3月8日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Onset and duration of sensory and motor block (using HOLLMEN SCALE) using 0.5% Ropivacaine and dexmedetomidine as adjuvant

研究概览

简要总结

Regional anesthesia techniques have advantages including excellent pain control, reduced side- effects, and shortened stay in the post anesthesia 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 and Dexamethasone is used to reduce the onset time, prolong the analgesic, and motor blockade effect without the systemic side effects and reduce total dose of local anesthetic requirement. Here, in our study we determine the duration of analgesia and compare the hemodynamic parameters with two different drugs of Dexmedetomidine and Dexamethasone with 0.5% Ropivacaine. We also try to find any adverse reaction to the study drugs. A total of 52 patients undergoing upper limb surgeries will be divided into two groups: Group A and Group B by block randomization. Group D will receive 20 ml of 0.5% Ropivacaine with 2 ml of 20 mcg Dexmedetomidine and Group X will receive 20 ml of 0.5% Ropivacaine with 2 ml of 8mg Dexamethasone. Duration of analgesia, onset of sensory and motor block, 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 depicted whenever possible, statistically analyzed 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

  • Patients of age group 18 to 60 years.
  • Patients of American Society of Anaesthesiologists (ASA) physical status grade I or II.

排除标准

  • Patients with hypertension, diabetes mellitus, autonomic neuropathy, peripheral nerve injury
  • Pregnancy or lactation.
  • Patients on anticoagulants or bleeding disorders.
  • Uncooperative/unwilling patients.
  • Local site infection.

结局指标

主要结局

Onset and duration of sensory and motor block (using HOLLMEN SCALE) using 0.5% Ropivacaine and dexmedetomidine as adjuvant

时间窗: Baseline and time when patient complains of pain and can start moving his limbs

次要结局

  • Onset & duration of sensory & motor block (using HOLLMEN SCALE) using 0.5% ropivacaine & dexamethasone as adjuvant(Baseline & time taken for patient to feel pain & move limbs)

研究者

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

Arivumadhi Sankar

Regional Institute of Medical Sciences

研究点 (1)

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