Could a simple inhaled mist stop Post-Spinal headaches in new moms?
NCT ID NCT06607861
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times
Summary
This study tests two inhaled medicines—dexmedetomidine and lidocaine—to treat severe headaches that can happen after spinal anesthesia during planned C-sections. About 114 women with moderate to severe headaches will receive one of the treatments through a nebulizer (a machine that turns liquid into a mist to breathe in). The goal is to see if these inhaled drugs can safely reduce pain and avoid the need for more invasive procedures like a blood patch.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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114 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fayoum university
Al Fayyum, 61511, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Eye-Opening clue: ultrasound of the optic nerve may predict spinal headache after C-Section
- Spinal headache study: does pregnancy affect pain after anesthesia?
- Leg workouts may stop spinal headaches after C-Section
- Inhaled drug combo may ease spinal headache after C-Section
- New drug combo aims to stop spinal headaches before they start
- Which drug best stops spinal headaches? new study aims to find out