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临床试验/CTRI/2025/04/084011
CTRI/2025/04/084011尚未招募Phase 3 4

A Double Blind Randomized Controlled Trial for analgesic role of Dexmedetomidine vs Dexamethasone as adjuvant in Axillary Brachial plexus block in forearm and hand surgeries.

Department of Anaesthesiology College of Medicine and Sagore Dutta Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
To compare the mean analgesic duration between two groups.

研究概览

简要总结

Patient compliance and duration of analgesia are two very important aspects of anaesthetic care. Therefore, in recent times it is quite essential to formulate better combination of drugs that provide adequate analgesia for longer duration. Dexamethasone has commonly been used for extension of spinal anaesthesia duration. Alpha-2 agonists are often mixed with local anaesthetic agents to extend the duration of spinal, epidural and peripheral nerve blocks. Our study will compare the efficacy of dexmedetomidine as adjuvant to 0.5% Levobupivacaine versus dexamethasone as adjuvant to 0.5% Levobupivacaine for prolongation of duration of analgesia with axillary brachial plexus block in forearm and hand surgeries.

There is paucity of studies comparing Dexamethasone and Dexmedetomidine with local anaesthetic agents in axillary brachial plexus block. Hence, the study will be beneficial to compare the effect of an alpha 2 agonist with respect to a steroid when used with a local anaesthetic agent in prolonging the duration of analgesia.

Expected outcome: The use of dexmedetomidine as an adjuvant to 0.5% levobupivacaine should provide longer duration of analgesia than dexamethasone as an adjuvant to same drug. Both the drugs are haemodynamically stable but slightly more bradycardia is seen with dexmedetomidine. In the outcome of our proposed study, it will be determined whether there is any significant difference in prolonging the duration of analgesia and reducing postoperative pain while using dexmedetomidine with respect to dexamethasone as adjuvants to 0.5% levobupivacaine in axillary brachial plexus block and to assess different adverse effects of both.

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

  • ASA Grade I and II.
  • Enrolled for elective forearm and hand surgery under axillary brachial plexus block.

排除标准

  • Patient refusal for either the axillary brachial block or participation in the study.
  • Any hypersensitivity or contraindication to study drugs.
  • Pregnant or lactating mothers.
  • Hepatic, renal, or cardiopulmonary abnormality.
  • Chronic alcoholism, uncontrolled hypertension, diabetes, long-term drug therapy.
  • Bleeding diathesis, local skin site infections.
  • History of significant neurological, psychiatric, or neuromuscular disorders (generalized or regional).
  • Patients who have undergone any other clinical trial within the last 3 months.

结局指标

主要结局

To compare the mean analgesic duration between two groups.

时间窗: 6 hours and 12 hours in post-operative period.

次要结局

  • 1. To compare the onset time of sensory & motor block among the two groups.(2. To compare the haemodynamic changes (heart rate & mean blood pressure) among two groups.)

研究者

发起方
Department of Anaesthesiology College of Medicine and Sagore Dutta Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Hena Ahmed Khan

College of Medicine and Sagore Dutta Hospital

研究点 (1)

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