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临床试验/CTRI/2025/11/097041
CTRI/2025/11/097041尚未招募2 期

A comparative study between dexmedetomidine and dexamethasone as adjuvants to 0.5 percent ropivacaine in ultrasound guided supraclavicular brachial plexus block.

Sapthagiri Institute of Medical Sciences and REsearch Centre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1)Onset and duration of sensory block

研究概览

简要总结

Patients fulfilling the inclusion criteria and posted for upper limb surgeries will be assigned to either group A and group B through a computer-generated random numbers, maintaining a equal ratio. Group A patients will receive 30 ml of 0.5 percent Ropivacaine with Dexmedetomidine 50micrograms and Group B will receive 30 ml of 0.5 percent Ropivacaine with 8milligram of Dexamethasone. Under Ultrasound guidance supraclavicular  brachial plexus block will be given, onset of sensory and motor block will be noted. Duration of sensory and motor block will be assessed 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery. Post-operatively, sensory and motor blockade and  vital parameters will  be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.The block will be considered incomplete when any of the segments supplied by median, radial, ulnar and musculocutaneous nerve did not have analgesia even after 30min of drug injection. Then such patients will be converted to general anaesthesia and will be excluded from the study. There is limited literature available comparing Dexmedetomidine and Dexamethasone as an adjuvant to ropivacaine in supraclavicular brachial plexus block. Hence, the present study will be undertaken to compare the efficacy of Dexmedetomidine and Dexamethasone as an adjuvant to ropivacaine in supraclavicular brachial plexus block in terms of onset and duration of sensory and motor block and duration of post operative 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.Patients undergoing unilateral upper limb surgeries.
  • 2.Patient willing to give informed consent.
  • 3.Age between 18yrs to 60yrs.
  • 4.ASA-PS 1 and
  • 5.Weight more than 60kgs.

排除标准

  • 1.Patients refusal.
  • 2.Allergy to local anesthetics and study drugs.
  • 3.Local infections.
  • 4.Bleeding disorders.
  • 5.Patient with neurological psychiatric and neruormuscular disorders.
  • 6.Patient with history of hepatic, renal, cardiopulmonary abnormalities.

结局指标

主要结局

1)Onset and duration of sensory block

时间窗: Every 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery.Postoperatively sensory and motor block assessement will be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.

2)Onset and duration of motor block

时间窗: Every 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery.Postoperatively sensory and motor block assessement will be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.

3)Time of rescue anlagesia

时间窗: Every 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery.Postoperatively sensory and motor block assessement will be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.

次要结局

未报告次要终点

研究者

发起方
Sapthagiri Institute of Medical Sciences and REsearch Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Harshitha N G

Sapthagiri Institute Of Medical Sciences

研究点 (1)

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