Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
Post-dural puncture headache (PDPH) is a common and debilitating complication of spinal anesthesia in pregnant patients undergoing cesarean sections, with an incidence ranging from 0.5% to 2% (1). The International Headache Society (IHS) defines PDPH as a headache occurring within 4 days of a lumbar puncture, caused by cerebrospinal fluid (CSF) leakage through the dural puncture (2). Although the exact cause of PDPH is not fully understood, it is thought to occur due to cerebrospinal fluid loss through dural tears, which leads to tension on pain-sensitive intracranial structures and reflex, uncontrolled cerebral vasodilation leading to severe agonizing tension headache (3). Treatment options include proper hydration, maintaining a supine position, caffeine, paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs). Many adjuvants have been questioned for their therapeutic effectiveness in enhancing conservative medical treatments, with conflicting results (4). For example, sumatriptan, theophylline and dexmedetomidine have been extensively studied. Neostigmine has emerged as a promising pharmacological adjuvant for conservative management. Neostigmine increases the serum level of acetylcholine via inhibition of cholinesterase (5). This action mediates cerebral vasoconstriction via nicotinic receptors, thus antagonizing the unopposed vasodilatation occurred due to dural tear. Lidocaine, on the other hand, can mediate sphenopalatine ganglion block which is responsible for pain signals transmission from the face (6).
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-35 years old parturient with post partum headache after elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 [14] and Lybecker classification score ≥ 2
排除标准
- •Pregnancy induced hypertension
- •Emergency C.S
- •Asthmatic candidates
- •Previous history of migraine or trigeminal neuralgia
- •History of bronchial asthma
- •Post partum hemorrhage
- •Need for GA , failed spinal anesthesia
- •Patient refusal
研究组 & 干预措施
Lidocaine group
Nebulization of lidocaine 20% (60 mg) diluted in 4 ml of sterile saline 0.9% twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management
干预措施: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml (Drug)
Control group
Nebulization of 4 mL 0.9% saline twice daily for three days plus conventional management (consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management
干预措施: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml (Drug)
Neostgmine group
Nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine diluted in 0.9% sterile saline ( total volume 4 ml) twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management
干预措施: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml (Drug)
结局指标
主要结局
VAS score
时间窗: pre interventiomnal, 1hour, 3 ,6, 12, 24, 34, 48, 72, 96, 120 hours
Acute pain categorization. 10= severe umimaginable pain..... 7- 9= severe pain...4-6= moderate to severe pain ..3- 5= moderate pain .... 1-3= mild pain
次要结局
- number of patients in need for epidural blood patch(5 days)
- Lybecker headache(pre interventiomnal,12, 24, 48, 72 hours)
- Trans-cranial doppler(at onset of treatment, 24, 48, 72 hours)
- transcranial doppler(at enrollment, PREINTERVENTIONAL 24,48, 72 hours)
- procedure related complication(3 days)
- neural complications(7 days)
研究者
Mina Maher
Ass professor anesthesia and pain
Minia University
