A Multicenter Double Blinded Randomized Controlled Trial of the Efficacy of the Sphenopalatine Ganglion Block for the Treatment of the Postdural Puncture Headache After Labor Epidural
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Epidural Blood Patch
研究概览
简要总结
The purpose of the study is to assess the effectiveness of the SPG block with lidocaine vs. SPG block with placebo on preventing the need for EBP in women who develop PDPH after accidental dural puncture during placement of LEA for labor.
详细描述
The postdural puncture headache (PDPH) is a well-documented complication of dural puncture. Depending on a number of factors, the overall incidence of PDPH following unintended dural puncture with an epidural placement needle is typically around 50%, but can be as high as 70% for certain populations.(1, 2, 3)
The headache is characterized by being frontal or occipital in nature, with a typical onset of 6-72 hours after dural puncture. It is normally exacerbated by the upright position and improved by the supine position. Associated symptoms may include photophobia, nausea, vomiting, dizziness, tinnitus, neck stiffness, decreased hearing and visual changes. (2) These symptoms tend to be extremely debilitating in affected patients, severely limiting their functional capacity until the resolution of the headache.(2) The compromise is even greater when considering these women also need to care for a newborn, as the time after birth is important for forming attachment and encompasses many new obligations for the new mother.
The treatment of the PDPH often begins with conservative treatment including supportive therapies such as hydration, bed rest, acetaminophen, NSAIDs, and oral opioids. In addition, some evidence exists for the use of caffeine (1,2). While these do not hasten recovery, they may improve symptoms. For PDPH of all etiologies, 72% will resolve spontaneously in 7 days and 89% by 14 days. (1)
For patients with moderate to severe symptoms or long lasting headaches, the gold standard for treatment of headaches that do not resolve is the epidural blood patch (EBP) (1,2,4). This treatment has been shown to be effective in 70-98% of patients (1,2,4). However, it has numerous contraindications including: fever, infection, coagulopathy, active neurological disease, patient refusal. In addition, a potential complication is yet another dural puncture. Also, while the EBP is generally very safe, it is an invasive procedure with its own complications; it has been associated with very rare but serious complications including: moderate long-lasting backache, meningitis, epidural abscess formation, epidural hematoma formation, and neurologic deficit development. (5-8)
The sphenopalatine ganglion (SPG) is a parasympathetic ganglion with fibers that innervate the cerebral and meningeal blood vessels cause vasodilation and activation of nociceptive fibers in the meninges, which is perceived as referred pain from the head by the sensory cortex. (9) So blockade of these fibers can theoretically relieve headache symptoms from other causes. The SPG block has been safely used for many years to treat chronic facial or head pain from cluster headaches, trigeminal neuralgia, postherpetic neuralgia, atypical facial pain from cancer, and CRPS I and II. (9)
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-50
- •Post Dural Puncture Headache after documented accidental dural puncture during placement of LEA for labor and no better explanation for headache
- •onset of HA within 72 hours of delivery.
排除标准
- •true allergy to local anesthesia
- •Hereditary Hemorrhagic Telangiectasia
- •inability to understand pain scores and other questionnaires
- •inability to speak English
- •contraindication to acetaminophen or NSAIDs
- •temperature >38.5 C
- •prior Epidural Blood Patch done for this headache
研究组 & 干预措施
Lidocaine
Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of 2% lidocaine jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes on both sides simultaneously. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered two times per day at approximately 12 hour intervals.
干预措施: Lidocaine HCl Gel 2% (Drug)
Placebo
Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of nasal saline jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered up to two times per day at approximately 12 hour intervals.
干预措施: placebo gel (Drug)
结局指标
主要结局
Epidural Blood Patch
时间窗: 7 days after treatment with lidocaine or placebo block
Proportion of postpartum women with a postdural puncture headache (PDPH) requesting epidural blood patch (EBP)
次要结局
- Verbal Numerical Pain(30 minutes, 1 hour, 2, hour, 1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block)
- Verbal Functionality Score(1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block)
