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临床试验/NCT06607861
NCT06607861已完成1 期

Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia: A Randomized Bicentric Study

Minia University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Pain severity

研究概览

简要总结

Post-dural puncture headache (PDPH) is a well-recognized and potentially serious complication of subarachnoid block. While advancements in spinal needle design have reduced its incidence in recent years, PDPH still affects a notable percentage of post-partum patients undergoing spinal anaesthesia, with rates ranging from 0.5% to 2%. Factors such as female gender, pregnancy, young age, low body mass index, dilutional anemia, and the preference for neuraxial anaesthesia during caesarean section (CS) increase the vulnerability of obstetric patients to PDPH. Therefore, managing this complication is critically important in obstetric anaesthesia.

The exact cause of PDPH remains unclear, but there is substantial evidence suggesting that it stems from reduced cerebrospinal fluid (CSF) pressure due to continuous leakage through a dural tear, which exceeds the rate of CSF production. This imbalance can lead to PDPH, as even a modest loss of CSF volume (as little as 10%) can trigger traction on pain-sensitive intracranial structures when in an upright position, compounded by reflexive vasodilation.

Various treatment strategies have been proposed, typically including bed rest in a supine position, fluid therapy, analgesics, and medications such as sumatriptan and caffeine.

Dexmedetomidine (DEX) is a highly specific agonist of α2-adrenoreceptors known for inducing cooperative sedation, anxiolysis, and analgesia while minimizing respiratory depression. Additionally, it has been shown to mitigate the stress and inflammatory response triggered by surgical and anaesthetic procedures. Activation of α2-receptors in the substantia gelatinosa of the dorsal horn suppresses the firing of nociceptive neurons and inhibits the release of substance P. Furthermore, stimulation of these receptors in the locus coeruleus, a key modulator of nociceptive transmission, interrupts the transmission of pain signals, resulting in analgesia. Dexmedetomidine has been administered via intranasal and inhalational routes for various purposes, including premedication, sedation, and post-operative analgesia.

Lidocaine nebulized is a novel method used recently for PDPH. Intranasal lidocaine can offer sphenopalatine ganglion block which can facilitate acute pain reduction in PDPH.

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, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Post partum headache for parturient with elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 [14] and Lybecker classification score ≥ 2

排除标准

  • •Emergency caesarean section.
  • •Pregnancy induced hypertension
  • •Contraindications for sub-arachinoid block ( coagulopathy, infection )
  • •History of chronic headache, migraine, trigeminal neuralgia
  • •Refusal to participate
  • •History of cerebrovascular stroke
  • •Prior maxillofacial with nasal deformity, Recent nasal surgery (<3 months) Nasal polyposis or severe allergic rhinitis
  • •Severe OSA (AHI>30) , OBESITY HYPOVENTILATION SYNDROME, CENTRAL APNEA SYBDROME
  • •History of obstructive sleep apnea.

研究组 & 干预措施

Lidocaine group

Active Comparator

bilateral nebulization (60 mg) using a mucosal atomization device twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management

干预措施: lidocaine group (Drug)

Control group

Active Comparator

nebulization of 4 mL 0.9% saline twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management

干预措施: saline group (Drug)

Dex. group

Active Comparator

nebulization of 1 µg/kg dexmedetomidine diluted in 4 mL 0.9% saline twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management

干预措施: dexmedetomidine group (Drug)

结局指标

主要结局

Pain severity

时间窗: at enrollment,1,6, 12, 24,36, 48, 72 , 96, 120 hours

Visual analogue scale from 0 to ten . 0 = no pain. 1-3=mild pain, 4-6= moderate. 7- 10= severe un imaginable pain

次要结局

  • Transcranial doppler(at enrollment, 24,48,72, 120 hours)
  • transcranial doppler(at enrollment, 24,48,72, 120 hours)
  • transcranial doppler(at enrollment, 24,48,72, 120 hours hours)
  • leybecker classification(At enrollment, 1,6, 12,24,36,48, 72, 96, 120 hours)
  • NEED for epidural blood patch(72 hours during the invesigation)
  • Procedural related complications(72 hours from the procedure)
  • persistent symptoms(one week after hospital discharge)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mina Maher

Ass professor anesthesia and pain

Minia University

研究点 (1)

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