Pregabalin as Alternative to Epidural Blood Patch in Treatment of Postdural Puncture Headache: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- the incidence of complete relief
研究概览
简要总结
Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 21 to 65 years old,
- •both genders,
- •confirmed diagnosis of postdural puncture headache (PDPH)
排除标准
- •patient refusal
- •known allergy to the drug used in the study
- •patients with a history of convulsions
- •chronic headaches
- •contraindications to regional anesthesia (such as local infection and coagulation abnormalities).
- •Clinical indications of elevated intracranial pressure or associated risk factors
- •Deteriorated patients
研究组 & 干预措施
Group A (pregabalin group)
Received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.
干预措施: Pregabalin 75mg (Drug)
Group B (EBP group)
Received active therapy in the form of an EBP and Group C (control group) received conservative treatment.
干预措施: An epidural blood patch (EBP) (Biological)
Group C (the control group)
received conservative treatment.
干预措施: conservative treatment. (Combination Product)
结局指标
主要结局
the incidence of complete relief
时间窗: 48 hours
The incidence of complete relief, as reflected in the success rate of the intervention at 48 hours.
次要结局
- The intensity of the headache(48 hours)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University