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临床试验/CTRI/2025/09/095115
CTRI/2025/09/095115尚未招募2 期

Comparative study of nalbuphine and clonidine as an adjuvant to ropivacaine in ultrasound guided supraclavicular brachial plexus block: a prospective randomised study

Sapthagiri Institute of Medical Sciences And Research centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月29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
60
试验地点
1
主要终点
1.onset of sensory and motor blockade

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 N and group C through a computer-generated sequence of random numbers, maintaining a equal ratio. Patients will be allocated to one of the two groups, Group N will receive 30 ml of 0.5 percent Ropivacaine with 10mg Nalbuphine and Group C will receive 30 ml of 0.5 percent Ropivacaine with Clonidine 75 microgram. Under Ultrasound guidance brachial plexus block will be given, onset of sensory and motor block will be noted. Duration of sensory and motor block will be assessed every 5min for first 30min thereafter every 10 min till end of surgery. Post-operatively, sensory and motor blockade and vital parameters will be noted at 10min,30min and 1,2,4,6 and 12 hour after the end of 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 nalbuphine and clonidine as an adjuvant to ropivacaine in supraclavicular brachial plexus block. Hence, the present study will be undertaken to compare the efficacy of nalbuphine and clonidine 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 Outcome Assessor 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.Patient willing to give informed consent 2.Age between 18-60 years 3.ASA ( American society of Anesthesiologist) physical status I and II 4.Patients undergoing upper limb surgery and planned for supraclavicular brachial block.

排除标准

  • 1.Patients with diabetes, peripheral vascular diseases, neurological, cardiopulmonary or psychiatric diseases 2.Allergy to study medications.
  • 3.Local infections, Bleeding disorders.

结局指标

主要结局

1.onset of sensory and motor blockade

时间窗: every 5min for first 30min thereafter every 10 min till end of surgery. | Post-operatively, sensory and motor blockade and vital parameters will be noted at | 10min,30min and 1,2,4,6 and 12 hour after the end of surgery.

2.duration of sensory and motor blockade

时间窗: every 5min for first 30min thereafter every 10 min till end of surgery. | Post-operatively, sensory and motor blockade and vital parameters will be noted at | 10min,30min and 1,2,4,6 and 12 hour after the end of surgery.

3.duration of post-operative analgesia

时间窗: every 5min for first 30min thereafter every 10 min till end of surgery. | Post-operatively, sensory and motor blockade and vital parameters will be noted at | 10min,30min and 1,2,4,6 and 12 hour after the end of 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

Harshitha G

Sapthagiri Institute of Medical Sciences And Research Centre

研究点 (1)

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