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临床试验/NCT04515901
NCT04515901撤回不适用

Early Intervention Sphenopalatine Ganglion Blocks (SPGBs) Versus Standard Conservative Management of Post Dural Puncture Headache in Obstetric Patients - A Randomized Feasibility Study

McMaster University2 个研究点 分布在 1 个国家开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Enrollment rate

研究概览

简要总结

Postdural puncture headache (PDPH) is a severe, debilitating complication of dural puncture that can arise from insertion of an epidural or spinal needle for labour analgesia. Presently, the conservative treatment options for PDPH have limited effectiveness and the gold standard treatment for PDPH, an epidural blood patch, is an invasive intervention with the potential for serious complications. There is a growing number of case reports and retrospective studies that suggest a sphenopalatine ganglion block (SPGB) with local anesthetic may offer an effective, safe, and easy-to-administer treatment option for PDPH in postpartum patients. We aim to conduct a feasibility study to assess whether a randomized controlled trial is feasible comparing whether early intervention SPGB with the option for repeat, patient self-administered SPGBs versus current standard conservative management can reduce the severity and duration of PDPH pain and improve patient functional status.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-45
  • Confirmed PDPH as per ICHD-3 diagnostic criteria

排除标准

  • American Society of Anesthesiologists (ASA) class 4 and above
  • History of chronic headaches or migraines requiring prescription medication
  • Known nasal septal deformity or abnormality
  • Known allergy to amide anesthetics
  • Intrathecal catheters
  • Patients who received EBP on the initial presentation with PDPH who declined a trial of conservative management
  • Postpartum complication delaying maternal discharge

研究组 & 干预措施

SPGB

Experimental

Via a soft tip 20-gauge long IV catheter attached to a 3 mL syringe will be filled with 2 mL of 2% viscous lidocaine. The 2% viscous lidocaine will be administered according to the method of Barre.

干预措施: 2% lidocaine (Drug)

Placebo

Placebo Comparator

It will be adminstered the same as the experimental arm but with methylcellulose and cherry flavouring to match odour and taste.

干预措施: Placebo (Other)

结局指标

主要结局

Enrollment rate

时间窗: 6 months

Number of consented patients over number of number of eligible patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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