Nebulized dexmedetomidine versus lidocaine for post-dural puncture headache after elective cesarean
Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia: A Randomized Bicentric Study
This study tests whether a nebulized dose of dexmedetomidine or lidocaine can reduce moderate-to-severe post-dural puncture headache in women after elective cesarean under spinal anesthesia.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Trial ID | NCT06607861 on ClinicalTrials.gov |
What this trial studies
Women who develop post-dural puncture headache after elective cesarean under spinal anesthesia are assigned to receive nebulized dexmedetomidine, nebulized lidocaine, or nebulized saline. Pain intensity is measured using the visual analog scale (VAS) and Lybecker classification, and symptom changes are recorded after treatment. The protocol compares the three groups for headache relief and need for additional interventions. Safety and tolerability, including any effects related to nasal delivery or respiratory status, are also monitored.
Who should consider this trial
Good fit: Postpartum parturients who develop PDPH after elective cesarean under spinal anesthesia with VAS ≥ 4 and Lybecker classification score ≥ 2.
Not a fit: Patients with chronic headache disorders, recent nasal surgery or deformity, severe obstructive sleep apnea, BMI > 35, or other contraindications listed in the protocol are unlikely to benefit from the interventions tested.
Why it matters
Potential benefit: If successful, this could offer a simple, noninvasive nasal treatment to reduce PDPH symptoms and lower the need for invasive procedures like an epidural blood patch.
How similar studies have performed: While local anesthetics and alpha-2 agonists have supporting data for some perioperative pain uses, nebulized intranasal treatment specifically for PDPH is relatively novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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-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.
Where this trial is running
Al Fayyum
- Fayoum university — Al Fayyum, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.