Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section Double-blinded, Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The incidence of pruritis
研究概览
简要总结
The aim of this study is to assess the efficacy and potency of lidocaine infusion as a preventive measure on pruritus response after injection of 200 micro gram morphine with bupivacaine subarachnoid block, spinal anesthesia, in cesarean section.
详细描述
Neuraxial opioids (NO) are one of the most widely used methods for postpartum analgesia, for cesarean section analgesia, and many other surgical procedures.
The pruritus induced by NO is an unpleasant, subjective, and irritating sensation that causes scratching response.
Pruritus begins shortly after anesthesia, with the onset depending on the type, route and dosage of opioid used. Pruritus invoked by lipid-soluble opioids such as fentanyl and sufentanil is of shorter duration, and the use of the minimum or small dose from opioids in addition of local anesthetics seems to decrease the prevalence and the severity of itching. Pruritus invoked by intrathecal morphine is of longer duration and is difficult to treat. Intrathecal administration, of opioids reach peak concentrations in the cerebrospinal fluid almost immediately. ]. But, after epidural administration, there is a delay in the rise to peak concentration (10-20 min with fentanyl and 1-4 h with morphine).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to 40 years.
- •Weight from 50 to 90 kg.
- •Women undergoing Cesarean section.
排除标准
- •Patient with known allergies to lidocaine.
- •Preexisting pruritus.
- •Coexisting skin disorders.
- •Contraindications to spinal anesthesia.
- •Preeclampsia.
- •Eclampsia.
- •Major systemic diseases.
- •Refusal to participate.
- •Uses of any current drugs have potential effects on post-operative itching as steroidal ,nonsteroidal ,ondanstern, propofol, midazolam during study period.
研究组 & 干预措施
Lidocaine group
Patients will receive Lidocaine infusion for 6 hours
干预措施: Lidocaine (Drug)
Control group
Patients will receive normal saline infusion for 6 hours
干预措施: Saline (Other)
结局指标
主要结局
The incidence of pruritis
时间窗: 24 hours postoperatively
The incidence of pruritis will be classifies as moderate (affecting a larger area, such as face and arms or face and anterior surface of thorax, but not disturbing the patient, and therefore not requiring treatment) , severe (extensive or generalized, often disturbing the patient and may need treatment)or very sever(disturbing the patient and treatment was indicated).
次要结局
- The severity of pruritis(24 hours postoperatively)
研究者
Ayman Mohamady Eldemrdash
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Aswan University