The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Degree of postoperative pain
研究概览
简要总结
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery
详细描述
Post amputation pain remains an extremely challenging pain condition to treat, so the prevention of phantom pain is our goal to decrease its incidence.
Methylene blue, an inhibitor of nitric oxide synthase and guanylate cyclase, has been widely applied for a variety of pain-related diseases due to its characteristic abilities, such as the blocking of pain transmission, antioxidant, and anti-inflammatory effects. Methylene blue can maintain local anesthesia for approximately 20 days so it can be used as a nerve block to relieve pain, especially refractory neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both genders, suffering from vascular insufficiency of one or both lower limbs and scheduled for above or below knee amputation under general anesthesia.
排除标准
- •Patients with a history of allergy to local anesthetics.
- •Patients with allergy to methylene blue.
- •Anticoagulant use or coagulopathy.
研究组 & 干预措施
Bupivacaine saline group
Patients in this group will receive the following regimen through the perineural catheter:
Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively
干预措施: bupivacaine saline (Drug)
Bupivacaine methylene blue group
Patients in this group will receive the following regimen through the perineural catheter:
Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively
干预措施: Bupivacaine methylene blue (Drug)
结局指标
主要结局
Degree of postoperative pain
时间窗: 3 days after surgery
Degree of postoperative pain will be assessed using visual analogue scale which is a 10 cm scale ranging from (0 = no pain to 10 = worst possible pain)
次要结局
- Incidence of phantom limb pain(9 months after surgery)
研究者
Osama Rehab
lecturer of anesthesiology, surgical intensive care and pain medicine
Tanta University