Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | nebulization of 4 mL 0.9% saline twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management |
|
| Dex. group | Active Comparator | nebulization of 1 µg/kg dexmedetomidine diluted in 4 mL 0.9% saline twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management |
|
| Lidocaine group | Active Comparator | bilateral nebulization (60 mg) using a mucosal atomization device twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol plus 130 mg caffeine every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline group | Drug | nebulization of 4 mL 0.9% saline twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at enrollment,1,3,6, 12, 24,36, 48, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| leybecker classification | degree of headache ... <2 = mild pain.. > 2= severe pain | At enrollment, 1,3,6, 12,24,36,48, 73 hours |
| Transcranial doppler | Measuring mean flow velocity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum university | Recruiting | Al Fayyum | 61511 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| at enrollment, 24,48,72 hours |
| 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. | 72 hours during the invesigation |
| Procedural related complications | hypotension, bradycardia | 72 hours from the procedure |
| persistent symptoms | Tinnitus, photophobia, orthostatic hypotension | one week after hospital discharge |
| transcranial doppler | pulsatality index | at enrollment, 24,48,72 hours |
| transcranial doppler | resisitive index | at enrollment, 24,48,72 hours |