Effect of Verapamil as an Adjuvant to Bupivacaine in Supraclavicular Brachial Plexus Block Guided by Ultrasound for Forearm and Hand Surgeries
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- duration of postoperative analgesia.
研究概览
简要总结
Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult.
详细描述
Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, a2 agonists (i.e. clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone.
The investigators will use calcium channel blocker as adjuvant to bupivacaine in supraclavicular block. Calcium plays an important role in analgesia produced by local anesthetics. The activation of N-methyl-D-aspartate receptors may lead to calcium entry into cells and potentiation of spinal cord and plays a role in pain formation. Hence, calcium channel blockers may prevent central sensitization and provide better sensory motor block characteristics. Verapamil, a calcium channel blocker can potentiate analgesic action of local anesthetics and reduce postoperative pain and analgesic consumption. Few studies were there using 2.5 mg of verapamil, showing no effect on onset and duration of sensory motor block. Hence, the investigators have used 5 mg of verapamil as adjuvant to bupivacaine. The primary aim of the study was to know whether verapamil (5 mg) as adjuvant to bupivacaine in supraclavicular brachial plexus block would delay the need of rescue analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :
- •fracture radius and ulna.
- •cut wrists.
排除标准
- •allergy to the study drugs,
- •skin infection at site of needle puncture,
- •significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.
研究组 & 干预措施
Group (A) : 30 patients (control group):
Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .
干预措施: complete blood count (Diagnostic Test)
Group (A) : 30 patients (control group):
Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .
干预措施: prothrombin time (Diagnostic Test)
Group (B) : 30 patients (verapamil group):
Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
干预措施: prothrombin time (Diagnostic Test)
Group (A) : 30 patients (control group):
Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .
干预措施: prothrombin concentration (Diagnostic Test)
Group (B) : 30 patients (verapamil group):
Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
干预措施: complete blood count (Diagnostic Test)
Group (B) : 30 patients (verapamil group):
Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
干预措施: prothrombin concentration (Diagnostic Test)
Group (B) : 30 patients (verapamil group):
Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
干预措施: Verapamil (Drug)
结局指标
主要结局
duration of postoperative analgesia.
时间窗: in first 24 hours
blinded observer will collect the Visual Analogue Score (VAS) for pain scored from Zero to ten where 0= no pain and 10 = the worst pain imaginable for acute post-operative pain.
次要结局
未报告次要终点
研究者
Mohamed Hosny Sayed
Principal Investigator
Assiut University