A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Duration of Effect
研究概览
简要总结
This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.
详细描述
In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator.
Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts.
Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age-18years and above
- •Both male and female patients
- •Elective Subacute upper extremity fractures
排除标准
- •Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)
- •Patients with drug abuse history in the past 6 months
- •Hepatic failure
研究组 & 干预措施
ropivacaine only
0.5% ropivacaine
干预措施: ropivacaine (Drug)
ropivacaine with dexmedetomidine
25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine
干预措施: Dexmedetomidine (Drug)
ropivacaine with dexmedetomidine
25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine
干预措施: ropivacaine (Drug)
结局指标
主要结局
Duration of Effect
时间窗: Immediate pre-op until 36hours post block
To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.
次要结局
- Potential Side Effects(Immediate pre-op until 36hours post block)