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临床试验/CTRI/2018/08/015389
CTRI/2018/08/015389尚未招募不适用

A comparative study of dexmedetomidine by two different routes as an adjunct to bupivacaine in usg guided supraclavicular block for upper limb surgeries-A prospective randomized placebo controlled triple blind study

Dr RPGMC Kangra at Tanda1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To study and compare the onset and duration of sensory and motor blockade with two different routes of dexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacaine in ultrasound guided supraclavicular brachial plexus block in patients scheduled for upper limb orthopaedic surgeries

研究概览

简要总结

The purpose of this study is to compare the onset andduration of sensory and motor blockade with two different routes ofdexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacainein ultrasound guided supraclavicular brachial plexus block. Thestudy will be conducted for a period of 12 months. It will be a prospective,triple blind placebo control trial study. The patients will be allocated one ofthe three groups by block randomization. The study drug solution will be preparedby anesthesiologist not involved in the study. The anesthesiologist performingthe block and anesthesiologist observing the patient, both will be blinded tothe study groups. Data will be analyzed by the anesthesiologist who will beunaware of the group allocation.

The enrolled patients after fulfilling all theinclusion and exclusion criteria will be divided into 3 groups.(i) **Group B (n=30) Control Group –**20 ml of 0.5%Bupivacaine +1ml Normal Saline and 1ml Normal Saline intramuscular.(ii) Group BD (n=30) **Dexmedetomidine Group****–**20 ml of 0.5% Bupivacaine + 50µg Dexmedetomidine in 1ml Normal Saline and 1ml Normal Salineintramuscular.(iii)Group BDIM (n=30) Dexmedetomidine IM Group **–**20 ml of 0.5% Bupivacaine + 1ml Normal saline and 1µg/kg Dexmedetomidine intramuscular.(A total volume of 21ml will begiven in brachial plexus block)

Sensory and motor blockade will be assessed interritories of three nerves (radial, ulnar and median)  for every 3 min after completion of injectiontill 30 minutes and then for every 30 minutes after the end of surgery till thefirst 12 h, thereafter hourly until the block will have completely worn off.Sensoryblock (three nerve territories) will be assessed by pin prick test using a3-point scale: 0 = normal sensation, 1 = loss of sensation of pin prick(analgesia), and2 = loss of sensation of touch (anesthesia) on dorsum of handaround anatomical snuff box for radial nerve, on hypothenar eminence for ulnarnerve, on medial side of thenar eminence for median nerve.  Motor block will be determined by thumbabduction (radial nerve), thumb adduction (ulnar nerve), thumb opposition(median nerve). Further block assessment will be done at hourly intervals up to24 hours by a blinded anesthesiologist.

The primary outcome measure in this study will bethe time to first analgesic request.

The secondaryoutcome measures include the number of supplemental analgesic requirements, VASpain, nausea, patient satisfaction and onset and duration of sensory block andmotor block episode of hypotension and bradycardia.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA class I-II
  • BMI 18.5-29.9
  • Undergoing surgeries around midarm, elbow, forearm and hand.

排除标准

  • Patient’s refusal for block
  • History of cardiac, renal or hepatic disease, CNS disorders,neuropathy
  • Patients having bleeding disorders
  • Hypersensitivity to local anesthetics
  • Local infection at the site where needle for block is to be inserted
  • Patients noted to have dysrhythmias on the electrocardiogram (ECG)
  • Allergic to study drugs
  • Patients in whom the block effect will be partial and will require supplementary anesthesia.

结局指标

主要结局

To study and compare the onset and duration of sensory and motor blockade with two different routes of dexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacaine in ultrasound guided supraclavicular brachial plexus block in patients scheduled for upper limb orthopaedic surgeries

时间窗: 24 hours

次要结局

  • To study and compare sedation with different routes of dexmedetomidine(24 HOURS)
  • •To study and compare the hemodynamic stability of two different routes of dexmedetomidine.(24 HOURS)
  • To observe for side effects of dexmedetomidine in two different routes, if any.(24 HOURS)

研究者

发起方
Dr RPGMC Kangra at Tanda
申办方类型
Government medical college

研究点 (1)

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