跳至主要内容
临床试验/CTRI/2018/02/012083
CTRI/2018/02/012083招募中不适用

comparison of efficacy of adding dexmetedomine versus fentanyl to bupivacaine in brachial plexus block.

Department of Health and Family Welfare1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
duration of post-operative analgesia

研究概览

简要总结

In this study patient who will  be fulfilling the inclusion criteria will be assesed preoperatively and all investigation will be noted. on the day of surgery procedure will be explained to the patient  and conset will be taken. peri operative vitals will be noted. all patient would be premedicated with ondensetron (0.15 mg/kg) 15-30 min prior to block. following skin preparation brachial plexus block will be performed under ultrasonographic technique using stimuplex needle after negative aspiration of air and blood, drug will be injected & proper spread of drug around plexus is continuosly evaluated. brachial plexus block will be performed on group BD (n=30) with 35 ml 0.375% bupivacaine +50 microgram dexmetedomine(1mcg/kg) while group BF (n=30) would receive block with 35ml 0.375% bupivacaine and fentanyl 75 microgram (1.5 mcg).

ONSET OF SENSORY BLOCK- it will be time taken from the end of injection to the first no response to pinprick in the distribution of any three sensory nerve in hand

sensory score

0 normal sensation to pin prick

1 dull sensation to pin prick

2 no sensation to pin prick

ONSET OF MOTOR BLOCK-it will be time from injection until onset of complete loss of motor power

motor score

0 normal motor function with full flexion and extension elbow,wrist and finger

1 decreased motor strength with  ability to move fingers only

2 complete motor blockade with inablity to move fingers

Duration of sensory block (the time taken between onset of sensory block and appearance of pain requiring analgesia ) Duration of motor block (time taken between onset of motor block to complete return of motor power) will be recorded. pain will be assessed  using Visual Analog Scale (VAS) where 0=no pain and 10=worst imaginable pain . good pain relief is defined as VAS<4 ,once this score is reached ,rescue analgesic inj Tramadol (1.5mg/kg) iv will be given. in post operative period heart rate, blood pressure ,VAS, Ramsay sedation score,time taken for first rescue analgesic will be recorded at 2,6,12,18,24 hrs postoperatively

研究设计

研究类型
Observational

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 I & II SCHEDULED FOR UPPER LIMB SURGERIES.

排除标准

  • patient refusal patients with history of cardiac,respiratory,renal or hepatic failure coagulation disorder local infection at the site of block psychological disorders allergy to study medications chronic use of pain medication patient with h/o substance abuse & current opiod use.

结局指标

主要结局

duration of post-operative analgesia

时间窗: duration of post-operative analgesia 24 hrs after surgery

次要结局

  • to observe onset and duration of sensory and motor effect,peri-operative hemodynamic changes and any complications.(intra-operative and 24 hrs post-operative period)

研究者

发起方
Department of Health and Family Welfare
申办方类型
Government medical college

研究点 (1)

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