Nebulized Dexmedetomidine for Post Dural Puncture Headache
Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia
Recruiting
Early Phase 1Interventional Study
Pain Score (VAS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 40
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
114 (estimated)
Sponsor
Minia University · Other
Who this trial is looking for
This trial is looking for postpartum patients who have a headache after a cesarean section with spinal anesthesia. Participants will be treated with nebulized dexmedetomidine to help reduce their pain.
Are You a Good Fit for This Trial?
You may be able to join if
I have a headache after my cesarean section.
My pain score is 4 or higher on the visual analog scale.
My Lybecker classification score is 2 or higher.
You may not be able to join if
I had an emergency cesarean section.
I have pregnancy-induced hypertension.
I can't have a spinal block due to health issues.
I have a history of chronic headache or migraine.
I refuse to participate.
I have had a stroke.
My BMI is over 35.
I have severe obstructive sleep apnea.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 mas…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Post partum headache for parturient with elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 \[14\] and Lybecker classification score ≥ 2
Exclusion Criteria:
* Emergency caesarean section.
* Pregnancy induced hypertension
* Contraindications for sub-arachi…
Inclusion Criteria:
* Post partum headache for parturient with elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 \[14\] and Lybecker classification score ≥ 2
Exclusion Criteria:
* 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
* BMI\> 35
* 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.
Contacts
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