Actively Recruiting

Early Phase 1
Age: 20Years - 40Years
FEMALE
NCT06607861

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

Led by Minia University · Updated on 2026-04-23

114

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 20 to 40 years
  • Postpartum headache after elective cesarean section under spinal anesthesia
  • Visual analog score (VAS) of 4 or higher for headache pain
  • Lybecker classification score of 2 or higher
Not Eligible

You will not qualify if you...

  • Emergency cesarean section
  • Pregnancy-induced hypertension
  • Contraindications for subarachnoid block such as coagulopathy or infection
  • History of chronic headache, migraine, or trigeminal neuralgia
  • Refusal to participate
  • History of cerebrovascular stroke
  • Body mass index (BMI) over 35
  • Prior maxillofacial surgery with nasal deformity, recent nasal surgery within 3 months, nasal polyposis, or severe allergic rhinitis
  • Severe obstructive sleep apnea (AHI over 30), obesity hypoventilation syndrome, or central apnea syndrome
  • History of obstructive sleep apnea

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fayoum university

Al Fayyum, Egypt, 61511

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia | DecenTrialz