Comparative Clinical Study Of Dexmedetomidine And Clonidine As Adjuvants To Levobupivacaine In Supraclavicular Brachial Plexus Block In Upper Limb Surgeries.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of
研究概览
简要总结
Regional blocks have secured a pivotal role in modern anaesthetic practice with their ability to achieve ideal operative conditions without much of systemic side effects. They offer an excellent alternative for patients who are hemodynamically compromised or too ill to tolerate general anaesthesia . For the majority of upper limb surgeries carried out on a daily basis, supraclavicular brachial plexus blockade is the technique of choice due to its effectiveness in terms of success rates, margin of safety, and efficient postoperative analgesia .
The first supraclavicular brachial plexus block was performed by Kulenkampff D in 1912 .Though relatively new, ultrasonographic visualization of the targeted nerves shows promise for the future. This makes it possible to see the block needle, the distribution of local anesthetic, and peripheral nerves directly. Past few years have observed a great increase in the use of ultrasound for regional nerve blocks.
An ideal drug should have a fast sensory onset, differential offset, with an earlier offset of motor than sensory blockade, enabling early ambulation or movements with prolonged analgesia. Several combinations of LAs and adjuvants such as tramadol, sufentanil, clonidine and fentanyl have been employed in the search for near ideal agent, which has proven to be unattainable
Currently, levobupivacaine ie S enantiomer of bupivacaine with favorable clinical profile and lesser cardiotoxicity when compared with racemic bupivacaine is being favoured LA for regional block.
Dexmedetomidine, a pharmacologically active dextro-isomer of medetomidine, is a selective alpha 2 adrenoceptor agonist employed for use as an adjuvant during regional anaesthesia.It inhibits the neuronal conduction by blocking hyperpolarization activated cation currents and produces analgesia.
Dexmedetomidine has been added perineurally at various doses; however, the optimal dose is still unknown. Analgesia lasts longer at higher doses of dexmedetomidine, such as 1to 2 mcg per kg, but at the expense of more adverse effects, such as bradycardia and hypotension.There are very few studies which evaluated the efficacy of low dose ie 30mcg of dexmedetomidine as an adjuvant to local anaesthetic to prolong the block characteristics.
Clonidine had been used as an adjunct to local anaesthetic agents in various regional techniques to extend the duration of block. It is a centrally acting alpha-2 adrenergic agonist. It has been added perineurally at various doses; however, the optimal dose is still unknown. Analgesia lasts longer at higher doses of clonidine.
Hence this study aims to evaluate the efficacy of 0.5 mcg per kg dexmedetomidine with 0.5 percent levobupivacaine versus 1 mcg per kg clonidine with 0.5 percent levobupivacaine in ultrasound guided supraclavicular block which can be beneficial to Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists physical status 1 and 2 Body Mass Index less than 30 kg per m2.
排除标准
- •History of allergy to study drug.
- •Infection at the site of injection.
- •Coagulopathies.
- •Patients on Beta blockers.
- •Neurological deficit in the operating arm.
- •Patients on anti psychotic and anti epileptic drugs.
结局指标
主要结局
To evaluate efficacy of Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of
时间窗: Time of completion of injection of local anaesthetic will be labelled as 0 minutes | After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick | onset and duration of motor block assessment will be done by bromage scale. | Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely. | Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved.
1.Onset of sensory blockade .
时间窗: Time of completion of injection of local anaesthetic will be labelled as 0 minutes | After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick | onset and duration of motor block assessment will be done by bromage scale. | Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely. | Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved.
2.Onset of motor blockade.
时间窗: Time of completion of injection of local anaesthetic will be labelled as 0 minutes | After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick | onset and duration of motor block assessment will be done by bromage scale. | Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely. | Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved.
3.Duration of sensory blockade
时间窗: Time of completion of injection of local anaesthetic will be labelled as 0 minutes | After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick | onset and duration of motor block assessment will be done by bromage scale. | Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely. | Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved.
4.Duration of motor blockade.
时间窗: Time of completion of injection of local anaesthetic will be labelled as 0 minutes | After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick | onset and duration of motor block assessment will be done by bromage scale. | Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely. | Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved.
5.Intensity of motor blockade.
时间窗: Time of completion of injection of local anaesthetic will be labelled as 0 minutes | After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick | onset and duration of motor block assessment will be done by bromage scale. | Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely. | Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved.
次要结局
- To evaluate postoperative analgesia with Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of(1.Visual analogue score for pain assessment.)
研究者
Dr Ajeet Jyotipurkar
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur