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Completed

NCT Number: NCT06607861

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

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Fayoum university

Al Fayyum, 61511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline group

Drug

nebulization of 4 mL 0.9% saline twice daily

Other names: nebulization of 4 mL 0.9% saline twice daily

dexmedetomidine group

Drug

nebulization of 1 µg/kg dexmedetomidine diluted in 4 mL 0.9% saline twice daily

Lidocaine group

Drug

bilateral nebulization (60 mg) using a mucosal atomization device twice daily

Primary outcomes

  1. Pain severity

    Time frame: 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

Secondary outcomes

  1. leybecker classification

    Time frame: At enrollment, 1,6, 12,24,36,48, 72, 96, 120 hours

    degree of headache ... <2 = mild pain.. > 2= severe pain

  2. Transcranial doppler

    Time frame: at enrollment, 24,48,72, 120 hours

    Measuring mean flow velocity

  3. NEED for epidural blood patch

    Time frame: 72 hours during the invesigation

    Visual analogue scale from 0 to ten . 0 = no pain. 1-3=mild pain, 4-6= moderate. 7- 10= severe un imaginable pain. Epidural blood patch if visual analogue scale more than or equal 4.

  4. Procedural related complications

    Time frame: 72 hours from the procedure

    hypotension, bradycardia

  5. persistent symptoms

    Time frame: one week after hospital discharge

    Tinnitus, photophobia, orthostatic hypotension

  6. transcranial doppler

    Time frame: at enrollment, 24,48,72, 120 hours

    pulsatality index

  7. transcranial doppler

    Time frame: at enrollment, 24,48,72, 120 hours hours

    resisitive index

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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