跳至主要内容
临床试验/CTRI/2020/06/025889
CTRI/2020/06/025889尚未招募不适用

Comparison of Anaesthetic efficacy of Ropivacaine and Ropivacaine with Nalbuphine as an adjuvant for Ultrasound guided Supraclavicular Brachial plexus blockade: A Randomized Controlled trial

Pondicherry Institute of medical science1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020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
70
试验地点
1
主要终点
To compare the duration of analgesia between ropivacaine and ropivacaine with nalbuphine for supraclavicular brachial plexus blockade

研究概览

简要总结

Ropivacaine is a long-acting regionalanesthetic that is structurally related to bupivacaine. It is a S(−)enantiomer, unlike bupivacaine, which is a racemate and  well-established long-acting regionalanesthetic, which like all amide anesthetics has been associated withcardiotoxicity when used in high concentration or when accidentallyadministered intravascularly. Hence ropivacaine was developed for the purposeof reducing potential toxicity and improving relative sensory and motor blockprofiles. Various adjuvants have been added to local anesthetics in brachialplexus block to achieve quick, dense, and prolonged block; however, the resultsare either inconclusive or associated with side effects.

Nalbuphine, a derivative of14-hydroxymorphine, is an agonist-antagonist opioid acting on µ (mu) receptorsas antagonist and κ (kappa) receptors as agonist with an analgesic potencyequal to morphine and its antagonistic potency is approximately ¼th ofthat of naloxone. Unlike morphine, it exhibits a ceiling effect on respiratorydepression. Nalbuphine has the potential to maintain or even enhanceµ-opioid-based analgesia while simultaneously mitigating the µ-opioid sideeffects.Therefore the purpose of this study is to compare by adding nalbuphine withropivacaine in supraclavicular brachial plexus block and to know its efficacy.

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 and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • American Society Of Anesthesiologists (ASA) Physical Status I To II Of Both Gender Age Between 18 And 60 Years Body Mass Index (BMI) <25 Kg/M2 Elective forearm and hand surgeries in orthopedic and plastic surgeries.

排除标准

  • Allergy to local anesthetics or Nalbuphine Infection at the injection site Patients with clinically significant coagulopathy Preexisting neuromuscular disorders Severe cardiovascular, or pulmonary disease, renal or hepatic disorder Pregnancy and lactation Patients taking medications with opioid or receiving chronic analgesic therapy other than simple analgesics were excluded from the study.

结局指标

主要结局

To compare the duration of analgesia between ropivacaine and ropivacaine with nalbuphine for supraclavicular brachial plexus blockade

时间窗: after complete sensory blockade

次要结局

  • To measure the onset of sensory and motor blockade and(To measure the duration motor blockade between the two study groups)

研究者

申办方类型
Private medical college

研究点 (1)

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