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临床试验/CTRI/2021/05/033641
CTRI/2021/05/033641尚未招募不适用

Comparison of analgesic efficacy of dexmedetomidine and buprenorphine as an adjuvant to levobupivacaine in patients undergoing fracture surgeries of upper limb performed under ultrasound guided infraclavicular block - a randomised control trial.

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
post operative analgesia using VAS pain scale

研究概览

简要总结

This study is a randomized single blinded trial comparing the effectiveness of adding dexmedetomidine and buprenorphine to infraclavicular levobupivacaine for fracture surgeries of upper limb that will be conducted in Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research. Primary outcome will be postoperative analgesia . Secondary outcome will be hemodynamic parameters( Heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation) , complete loss of sensation to pin prick to return of  sensation , onset of motor blockade and return to Bromage score 0 , and anticipated side effects.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant 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 physical status I or II patients Age 18–60 years, scheduled for surgeries of the forearm, wrist and hand under US-guided infraclavicular brachial plexus block.

排除标准

  • Patients aged <18 years or >60 years.
  • Patients having body weight <40 kg and >70 Kg. Any contraindication to regional anesthesia.
  • Refusal for infraclavicular block and inability to give consent Patients undergoing surgeries of arm, elbow, shoulder Patients having peripheral neuropathy or hypersensitivity to local anaesthetic agents.
  • Patients having history of seizures.
  • History of pulmonary, cardiac, hematological, endocrinal, and neuromuscular disorders.

结局指标

主要结局

post operative analgesia using VAS pain scale

时间窗: postoperative period 2nd,4th,6th,8th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th hour

次要结局

  • Hemodynamic parameters ( Heart rate, respiratory rate, systolic blood pressure,diastolic blood pressure, mean arterial pressure, oxygen saturation)(baseline, 2 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours)
  • Anticipated side effects(post operative period upto 48 hours)
  • Sensory block(complete loss of sensation to pin prick to return of sensation)(post operative period upto 48 hours)
  • Motor block ( onset of motor blockade and return to bromage score 0)(post operative period upto 48 hours)

研究者

研究点 (1)

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