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临床试验/CTRI/2023/06/054070
CTRI/2023/06/054070尚未招募4 期

To compare the analgesic efficacy of perineural and intravenous Dexamethasone as an adjuvant to 0.5% Ropivacaine for ultrasound guided brachial plexus block for upper limb surgeries: A randomised, triple blind placebo controlled trial.

DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年6月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Time of first analgesic request.

研究概览

简要总结

Supraclavicular brachial plexus block is considered to be one of the most effective approach for anesthesia for upper limb surgery. The brachial plexus is most compact at the level of the trunks formed by the C5–T1 nerve roots, so nerve block at this level has the greatest likelihood of blocking all of the branches of the brachial plexus.  The compactness of the brachial plexus in this location facilitates a rapid onset and complete block of the brachial plexus for procedures distal to the shoulder. Ultrasound guided supraclavicular brachial plexus block has improved the success rate of block with excellent localization as well as improved safety margin.The supraclavicular block is ideal for operations involving the arm and forearm.

Various local anesthetics like  Ropivacaine, Bupivacaine etc ,have been used with safety and efficacy in performing such blocks. Local anesthetics act on the voltage-gated sodium channels that conduct electrical impulses and mediate fast depolarization along nerves.  they target open channels and prevent ion flow. This act on potassium channels, but they block sodium channels more.They preferentially binds to the inactivated state of voltage gated sodium channels, but has also been found to bind potassium channels, G-protein coupled receptors, NMDA receptors, and calcium channels in vitro.

Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics can be reduced,thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Various adjuvants has been introduced with these agents to prolong the duration of blockade in long surgeries. Some of the additives used with local anesthetics include alpha2 agonists, NSAIDS, opioids, and glucocorticoids. Addition of long acting glucocorticoids like Methylprednisolone with local anesthetics have been used to treat chronic pain. Latest to this series is Dexamethasone which not only prolongs the analgesia but also decreases the local inflammation by inhibiting action of phospholipase A2 at the site of surgery. Dexamethasone helps by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge and inhibiting potassium channel-mediated discharge of nociceptive C-fibres.Addition of steroid to local anesthetics effectively and significantly prolongs the duration of analgesia as well as producing earlier onset of action in adults. Based upon previous studies as an adjuvant to regional analgesia perineural Dexamethasone significantly shortened the onset of sensory and motor block, prolong duration of analgesia, prolong the time to first analgesic request with minimal side effects. Intravenous Dexamethasone during general anesthesia has proven beneficial in reducing pain, postoperative nausea and vomiting, decreasing airway complications in patients with bronchial hyperreactivity  because of worry of physiochemical impacts from perineural adjuvants Dexamethasone, few authors have suggested against its use as an adjuvant to local anesthetic or have proposed that alternative route of administration i.e. intravenous are preferable. Dexamethasone has been used in different doses ranging between 1 to 8 mg. but it has been found that 1, 2 and 4 mg dexamethasone when added to 0.5% Ropivacaine resulted in similar prolongation of motor blockade and analgesia.

The present study is undertaken with null hypothesis that perineural and i.v administration of Dexamethasone have no clinical difference in terms of block characteristics.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • 1.Males and females between the age group18-65 years.
  • 2.ASA class I-II.
  • 3.BMI 18.5-29.
  • 4.Undergoing surgeries around mid-arm, elbow, forearm and hand.

排除标准

  • 1.Patient’s refusal for block.
  • 2.History of cardiac, renal or hepatic disease, CNS disorders, neuropathy.
  • 3.Patients having bleeding disorders.
  • Hypersensitivity to local anaesthetics and study drugs.
  • 6.Patients in whom the block effect will be partial and will require supplementary anaesthesia.

结局指标

主要结局

Time of first analgesic request.

时间窗: Time of first analgesic request after successful supraclavicular block.

次要结局

  • The secondary outcome measure include the number of supplemental analgesic requirements, VAS pain, patient satisfaction, random blood sugar.(Postoperatively the patients will be evaluated for pain at 4,6,12,18,24 hours with visual analog scale pain score. Sensory & motor blockade will be assessed every 2 min for first 20 mins, then every 5 mins till 40 mins, then every 15 mins till end of surgery & thereafter every 30 mins till recovery of sensory & motor block. Random blood sugar will be monitored every 4 hourly in post-operative period for 24 hrs. following Dexamethasone injection.)

研究者

发起方
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA
申办方类型
Government medical college

研究点 (1)

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