Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Headache intensity
研究概览
简要总结
The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.
详细描述
- To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.
- To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups.
- To detect any side effects of the study medications in all patient groups.
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
- Double (Participant, Outcomes Assessor)
盲法说明
anesthetist not sharing in the study will assess patient
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Both gender.
- •Age: 18- 65 years old.
- •Body Mass Index 20-30 kg/m2
- •American Society of Anesthesiologist (ASA) physical status I - II.
- •Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .
排除标准
- •- Allergy to study drugs.
- •History of chronic headache and migraine.
- •History of cerebrovascular accidents and neurological disorders.
- •Systemic infection
- •History of uncontrolled DM or hepatic disease or pregnant female
- •Patient refusal or uncooperative patient.
研究组 & 干预措施
group A
Group A (conservative treatment): oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days.
干预措施: caffeine, paracetamol tablet (Drug)
group B
Group B (oral prednisolone): patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days.
干预措施: Oral prednisolone (Drug)
group C
Group C (oral pregabalin): patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.
干预措施: oral pregabalin (Drug)
结局指标
主要结局
Headache intensity
时间窗: at 72 hours
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
pain intensity of headache
时间窗: at 72 hours
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
次要结局
- Associated symptoms of post dural puncture headache(for 72 hours)
- Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness(for 72 hours)
- total dose of rescue analgesia(for 72 hours)
研究者
Dina Abdelhameed Elsadek Salem
principal investigator
Zagazig University