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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Post partum headache for parturient with elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 [14] and Lybecker classification score ≥ 2

Disqualifiers

Emergency caesarean section.

Pregnancy induced hypertension

Contraindications for sub-arachinoid block ( coagulopathy, infection )

History of chronic headache, migraine, trigeminal neuralgia

Trial design

Design model

Parallel

Treatments tested in this trial

  • saline group

    Drug

    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

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Dex. groupActive comparator 1 intervention
Group C: Lidocaine groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain severity

Visual analogue scale from 0 to ten . 0 = no pain. 1-3=mild pain, 4-6= moderate. 7- 10= severe un imaginable pain

Time frame
at enrollment,1,3,6, 12, 24,36, 48, 72 hours

Secondary outcomes

1

leybecker classification

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

Time frame
At enrollment, 1,3,6, 12,24,36,48, 73 hours
2

Transcranial doppler

Measuring mean flow velocity

Time frame
at enrollment, 24,48,72 hours
3

NEED for epidural blood patch

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.

Time frame
72 hours during the invesigation
4

Procedural related complications

hypotension, bradycardia

Time frame
72 hours from the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.