Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to first requirement of analgesic supplement
研究概览
简要总结
The purpose of this study is to assess the effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section
排除标准
- •women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus
- •current or previous history of significant disease including heart disease, liver, renal disorders ,anemia (Hb8 g%)or known coagulopathy
研究组 & 干预措施
melatonin 3mg
干预措施: melatonin 3mg (Drug)
melatonin 6mg
干预措施: melatonin 6mg (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Time to first requirement of analgesic supplement
时间窗: Time to first requirement of analgesic supplement within 24 hours after intratechal injection
amount of blood loss after cesarean delivery
时间窗: during surgery
次要结局
- hemodynamic variables(5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection)
研究者
marzieh beigom khezri
Assistant professor
Qazvin University Of Medical Sciences
