Efficacy and Efficiency of Sphenopalatine Ganglion Block for Management of Post-dural Puncture Headache in Obstetric Patients-A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numeric rating pain score
研究概览
简要总结
The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients
详细描述
Background and objectives: Post dural puncture headache(PDPH) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal is the easiest, least invasive approach which can be done at bedside.
The objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.The following will be recorded: pain score will be assessed using the numeric rating pain scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction
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
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ASA I or II post caesarean section
- •Body weight between 60-100 kg
- •Active PDPH within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine.
排除标准
- •Patient refusal to participate in the study
- •Body mass index >35kg/m2
- •Patients with :coagulopathy ,nasal septal deviation,polyp
- •History of nasal bleeding
- •Allergy to local anesthetic
研究组 & 干预措施
Group A (Control group)
Patients will receive paracetamol 1 g thrice daily intravenously
干预措施: paracetamol (Drug)
Group B (Sphenopalatine ganglion block group)
patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone
干预措施: Sphenopalatine ganglion block (Procedure)
结局指标
主要结局
Numeric rating pain score
时间窗: First 24 hours after the procedure
Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH
次要结局
- Total analgesic consumption(First 24 hours after the procedure)
研究者
Marwa Mostafa Mohamed Ali Mowafi
Lecturer of anesthesia ,principal Investigator
Ain Shams University