Sphenopalatine Ganglion Block For Post-Dural Puncture Headache In Obstetric Parturients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess efficacy of SPG block in terms of pain relief after PDPH
研究概览
简要总结
Post-dural puncture headache (PDPH) is a major cause of morbidity in postpartum patients whoreceive neuraxial block for labour analgesia and/or caesarean delivery. Epidural blood patch (EBP) is the gold standard for its treatment, with a success rate upto 90%. However, it is likely to be associated with various adverse effects, like, subdural haematoma, infection, meningitis, and delayed radicular pain. Also, the procedure itself can cause another inadvertent dural puncture (DP). EBP is, therefore, never considered as the first line of management of PDPH. Patients are often offered conservative treatment including medications, bed rest, abdominal binders, and fluids for at least 24 hours prior to being offered an EBP. The sphenopalatine ganglion (SPG) block is found to be an effective treatment for PDPH in the obstetric population, the block could be offered to patients as a first-line treatment as a way to improve pain scores, reduce the need for medications with potential side effects, and possibly reduce the need for EBP. This randomized study done in 50 parturients aims to evaluate SPG block for management of PDPH in reducing the severity of pain and as a useful adjunct to the traditional treatment with oral or parenteral analgesics in this subset of patients. Parturients will be randomized into two groups:
Conservative group (Group C) – will receive IV paracetamol 1g 8 hrly
Sphenopalatine ganglion block group (Group S) - will receive SPG block
Parturients in both the groups will receive IV fluids (2L/day) and bed rest without pillow.
Relief from headache will be assessed as per the NRS score from 0-10 in supine and sitting position pre-intervention as well as 5min, 30min, 2h, 4h, 8h, 12h, 24h and 48h post-intervention. Time to first analgesic dose after the SPG block, relief in associated symptoms of PDPH, adverse effects associated with the block, need for EBP and parturient satisfaction will be assessed and compared between both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All consenting obstetric parturients aged 18-45 years who receive neuraxial block for labour or caesarean delivery with development of PDPH within 72 h of dural puncture will be eligible to participate.
排除标准
- •Parturient with chronic neurological disorder (epilepsy), bleeding disorder, allergy to local anaesthetics, deformity of the nasal septum, nasal polyps, frequent nosebleeds, those with nasal or sinus surgery within the past year or refusal to participate will be ineligible to participate.
结局指标
主要结局
To assess efficacy of SPG block in terms of pain relief after PDPH
时间窗: 5min, 30 min, 2h, 4h, 8h,12h, 24h and 48 h
次要结局
- A.To observe at different time intervals(1)Pain relief in supine and sitting position)