A comparative study between Clonidine and Buprenorphine as adjuvants to 0.5 percent Ropivacaine in Ultrasound guided Infraclavicular Brachial Plexus Block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. To evaluate and compare the onset for sensory blockade.
研究概览
简要总结
General anaesthesia was one of the most common methods employed to provide anaesthesia for upper limb surgeries. With the introduction of newer and safer local anaesthetics and better advantages, regional anaesthesia has taken over as the principal technique for upper limb surgeries.
Regional anaesthesia is comparatively safer and does not involve the potential side effects and complications that may arise from sedation and general anaesthesia. It is also effective as it more acceptable amongst the patients, thus providing the doctors an increased patient compliance and consent for surgery. The infraclavicular block is a safe and effective approach for Brachial plexus block that can provide anaesthesia for hands, wrist and forearm.
Ropivacaine is a propyl analogue of bupivacaine that has the same potency with longer duration of action and lesser cardiac and central nervous system toxicity of bupivacaine. Several adjuvants can be used to lengthen the duration of infraclavicular brachial plexus block such as clonidine, opioids, neostigmine, midazolam and buprenorphine[1].
Clonidine, a selective alpha-2 adrenergic agonist inhibits nociceptive impulses by activating postjunctional alpha-2 adrenoreceptors both at peripheral and spinal nerve endings. It improves block characteristics of local anaesthetics in peripheral nerve blocks without producing any side effects like sedation, bradycardia and hypotension as seen in spinal blocks[2].
Buprenorphine is a dehydroxylated phenanthrene and is chemically similar to other opioids such as hydrocodone, oxycodone, levorphanol, hydromorphone, oxymorphone, and others. Buprenorphine is a partial agonist at the m-opioid receptor (MOR) and an antagonist at k receptors. As a partial agonist, buprenorphine is able to activate MORs at low to moderate doses and it can achieve the same or superior analgesia compared to a full m-opioid agonist [3].
There are studies that compare the effects of adding clonidine as an adjuvant to ropivacaine or bupivacaine for brachial plexus blocks[1]. But there are limited studies with buprenorphine as an adjuvant in infraclavicular blocks.
After thorough research in literature, it was concluded that limited data is available that compares and assess the effects of these drugs as adjuvants to ropivacaine.
Hence, this study is being undertaken which intends to compare and evaluate the effects of clonidine and buprenorphine as adjuvants to ropivacaine in infraclavicular brachial plexus blocks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of either sex, aged 21-60 years, undergoing elective upper limb surgeries.
- •Patients belonging to American Society of Anesthesiologist (ASA) physical status I, II.
- •Patients within the weight range of 50-80kgs and within normal BMI.
排除标准
- •Patient refusal for the study.
- •Patients with coagulopathy or on anticoagulants.
- •Patients with pre-existing neuropathy involving brachial plexus.
- •Patients who have undergone prior surgeries of the infraclavicular fossa.
- •Patients with localized skin infections at site of block.
- •Patients with hypersensitivity to local anaesthetic.
结局指标
主要结局
1. To evaluate and compare the onset for sensory blockade.
时间窗: 5 mins | 10 mins | 15 mins | 20 mins | 25 mins | 30 mins | 1 hour | 2 hours | 3 hours | 6 hours | 12 hours | 24 hours
2. To evaluate and compare the onset for motor blockade.
时间窗: 5 mins | 10 mins | 15 mins | 20 mins | 25 mins | 30 mins | 1 hour | 2 hours | 3 hours | 6 hours | 12 hours | 24 hours
3. To evaluate and compare the duration of sensory blockade.
时间窗: 5 mins | 10 mins | 15 mins | 20 mins | 25 mins | 30 mins | 1 hour | 2 hours | 3 hours | 6 hours | 12 hours | 24 hours
4. To evaluate and compare the duration of motor blockade.
时间窗: 5 mins | 10 mins | 15 mins | 20 mins | 25 mins | 30 mins | 1 hour | 2 hours | 3 hours | 6 hours | 12 hours | 24 hours
次要结局
- 1. To assess hemodynamic variables.(2. To identify adverse effects to the drugs.)
研究者
Dr. Pramathesh A
Department of Anaesthesiology
