Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of pain using Visual Analogue Scale
研究概览
简要总结
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.
详细描述
The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent elective cesarean section under spinal anesthesia.
- •Patients aged 18 to 40 years old.
- •Patients classified as ASA I or II.
排除标准
- •Patients with known sensitivity to any of the used drugs.
- •Patients classified as ASA III or more.
- •Preeclampsia.
- •Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.
研究组 & 干预措施
control group
received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours
干预措施: Acetaminophen (Drug)
control group
received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours
干预措施: oral fluids (Other)
control group
received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours
干预措施: Caffeine (Drug)
control group
received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours
干预措施: Diclofenac (Drug)
Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
干预措施: Pregabalin 100Mg Oral Cap (Drug)
Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
干预措施: Acetaminophen (Drug)
Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
干预措施: oral fluids (Other)
Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
干预措施: Caffeine (Drug)
Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
干预措施: Diclofenac (Drug)
Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
干预措施: Hydrocortisone (Drug)
Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
干预措施: Acetaminophen (Drug)
Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
干预措施: oral fluids (Other)
Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
干预措施: Caffeine (Drug)
Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
干预措施: Diclofenac (Drug)
结局指标
主要结局
Assessment of pain using Visual Analogue Scale
时间窗: the first 48 hours following treatment
Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment
次要结局
- Assessment of the amount of rescue drug(The first 48 hours following treatment)
- incidence of side effects of the studied drug(the first 48 hours following treatment)
- incidence of side effect of the studied drug(the first 48 hours following treatment)
研究者
Nesrine El-Refai
professor
Cairo University