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临床试验/NCT06380764
NCT06380764已完成不适用

Greater Occipital Nerve Block at Two-levels Spares the Need for Epidural Blood Patch for Management of Postdural Puncture Headache

Benha University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2023年3月2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
已完成
入组人数
152
试验地点
1
主要终点
The extent of reduction of consumed analgesia

研究概览

简要总结

Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.

Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with postdural puncture headache;
  • Patients partially improved on conservative treatment and required a definitive pain relieving management;
  • Patients who were intolerant to conventional analgesics;
  • Patients who did not receive or did not improve on conservative therapies.

排除标准

  • Patients had postdural puncture headache who were improving on conservative treatment and refused further interventions;
  • Patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus;
  • Patients dependent on routine analgesia for other causes were excluded from the study;
  • Patients refused to participate in the study or to sign the written consent;
  • Patients missed during follow-up were not included in the study.

研究组 & 干预措施

First line Group

Active Comparator

干预措施: Greater Occipital Nerve Block (Procedure)

First line Group

Active Comparator

干预措施: Lidocaine 2% Injectable Solution (Drug)

Second line Group

Active Comparator

干预措施: Bilateral suboccipital intramuscular injection (Procedure)

Second line Group

Active Comparator

干预措施: Lidocaine 2% Injectable Solution (Drug)

Third line Group

Active Comparator

干预措施: Epidural Blood Patch (Procedure)

Placebo Group

Placebo Comparator

干预措施: Normal Saline 10 mL Injection (Drug)

结局指标

主要结局

The extent of reduction of consumed analgesia

时间窗: 7 months

Necessity of greater occipital nerve block as a management procedure to the postural puncture headache

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yehia Shahin Dabour

Lecturer at Department of Anesthesia, Pain, ICU, Faculty of Medicine

Benha University

研究点 (1)

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