Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
研究概览
简要总结
The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )
详细描述
This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •18-50 age
- •Fullterm singular pregnancy
排除标准
- •Neuraxial anesthesia is contraindicated,
- •Allergy to the drugs to be used in the study,
- •Refused to participate in the study,
- •BMI>35 kg/m2
- •Preeclampsia,
- •Cardiovascular disease
- •Chronic pain and neuropathic pain,
- •Given opioids in the operation due to intraoperative pain,
- •Switched to general anesthesia,
- •Excessive bleeding during the operation,
- •Uterine atony
- •Drain placed in the area to be infiltrated,
- •History of drug addiction and psychiatric illness,
- •Understand Visual analog pain scale
研究组 & 干预措施
Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI)
local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation
干预措施: Bupivacain (Drug)
Group morphine ( M )
intrathecal injection of morphine with local anesthesic
干预措施: Morphine hydrochloride (Drug)
结局指标
主要结局
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
时间窗: postoperative 24 hours
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
次要结局
- Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively(2,4,6,12,and 24 hours postoperatively)
研究者
Aysenur Dostbil
Clinical Professor
Ataturk University