Trans-nasal Sphenopalatine Ganglion Block Versus Intravenous Aminophylline Injection for Treatment of Postdural Puncture Headache After Caesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.
研究概览
简要总结
The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.
详细描述
Postdural puncture headache (PDPH) is a severe and debilitating complication after regional anesthesia in the obstetric population; The gold standard treatment for PDPH is epidural blood patch, which is an invasive and risky procedure.
The trans-nasal sphenopalatine ganglion (SPG) block and intravenous aminophylline are promising options for PDPH. So the investigators designed this randomized, double-blind study to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 - 40 years old female.
- •ASA I -II according to the American society of anesthesiologists.
- •Spinal anesthesia with 22G Quincke needle for cesarean section.
- •PDPH was defined according to the international classification of headache disorders, 3rd edition criteria (ICHD-3) as:
- •Headache occurring within 5 days of a lumbar puncture.
- •Orthostatic headache that significantly worsens soon after sitting upright or standing and/or improves after lying horizontally usually accompanied by neck pain, tinnitus, changes in hearing, photophobia, and/or nausea.
- •Exclusion of other causes such as hypertension, preeclampsia, tension headache, migraine, etc.
排除标准
- •A history of headaches that could interfere with the PDPH diagnosis,
- •A history of central nervous system diseases, including intracranial hemorrhage, seizures, intracranial hypertension, or hydrocephalus
- •A history of cardiovascular diseases, including coronary heart disease, arrhythmias, or hypertension.
- •A history of allergy to or any contraindication for using Aminophylline.
- •Coagulopathy.
- •Nasal septal deviation, polyp, or nasal bleeding.
- •General anesthesia after failed spinal anesthesia.
研究组 & 干预措施
Conservative therapy
will receive conservative therapy such as bed rest, fluids, abdominal binder, oral paracetamol, and caffeine
干预措施: conservative therapy (Other)
Aminophylline
will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
干预措施: conservative therapy (Other)
Aminophylline
will receive conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes)
干预措施: Aminophylline (Drug)
transnasal spheno-palatine ganglion block
will receive the conservative therapy plus transnasal spheno-palatine ganglion block under strict protective and safety measures against COVID-19, using a hollow cotton swab soaked in lidocaine 2% for 5 minutes in each nostril then 0.5ml of lidocaine 2% will be injected slowly through the hollow swab and repeated once after another 5 minutes where the patient will stay in the supine position for 10 minutes.
干预措施: conservative therapy (Other)
transnasal spheno-palatine ganglion block
will receive the conservative therapy plus transnasal spheno-palatine ganglion block under strict protective and safety measures against COVID-19, using a hollow cotton swab soaked in lidocaine 2% for 5 minutes in each nostril then 0.5ml of lidocaine 2% will be injected slowly through the hollow swab and repeated once after another 5 minutes where the patient will stay in the supine position for 10 minutes.
干预措施: trans nasal sphenopalatine ganglion block (Procedure)
结局指标
主要结局
the headache severity in the form of Visual Analogue score (VAS) at 12 hours after treatment.
时间窗: at 12 hours
0 - no pain to 10 - worst pain imaginable
次要结局
- Patient Global impression of change (PGIC) scale(at 24 hours)
- Adverse effects(at 24 hours)
研究者
Tamer Samir Abdelsalam
lecturer of Anesthesia
Ain Shams University