Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607861
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 05 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None