Porównanie gabapentynu podawanego doustnie, neostygminy/atropiny wstrzykiwanej dożylnie oraz kombinacji obu leków w zapobieganiu bólowi głowy po punkcji oponowej

ClinicalTrials.gov➕ 05.11.2026Status: Trwa rekrutacjaFaza: PHASE2, PHASE3

Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH

W skrócie

Badanie dotyczy bólu głowy, który pojawia się po punkcji oponowej (zabiegu anestezjologicznym). Pacjenci otrzymują jeden z trzech sposobów leczenia: tabletki gabapentynu, wstrzyknięcie do żyły mieszaniny neostygminy i atropiny, lub kombinację obu metod. Badanie ma na celu znalezienie najskuteczniejszego sposobu zapobiegania i leczenia tego powikłania u pacjentów, u których pojawia się silny ból głowy, szczególnie przy wstawaniu z łóżka.

Oryginalny opis (angielski)

Post-dural puncture headache (PDPH) is a major complication of neuraxial anaesthesia. Pain is intense, frontal, throbbing, and radiates to the occiput; it is more severe when standing and less severe when lying down. A lot of studies reported several techniques for management of post-dural puncture headache including conservative, pharmacological or interventional techniques. Conservative techniques such as hydration and bed rest. These therapies aim to decrease CSF loss through the dural hole and restore CSF with additional fluid intake. Pharmacological treatment such as caffeine , methylxanthine (as theophylline), gabapentinoids, Sumatriptan, cosyntropin, dexamethasone, intravenous (IV) injection of ondansetron and IV opioid were used. Also, there are several interventional treatments like), epidural blood patch greater occipital nerve block, and sphenopalatine ganglion block has been used. Neostigmine has a biphasic effect on sympathetic ganglia, ie, depolarization followed by hyperpolarization. results in vasoconstriction reflects sympathetic regulation of the blood supply to cerebral vessels . An increase in central acetylcholine can maintain cerebral vasoconstriction Atropine crosses the blood brain barrier and is a parasympatholytic , it increases CSF secretion by antagonizing the effect of acetylcholine on the choroid plexus Gabapentin is an anti-epileptic, similar in structure to the endogenous neurotransmitter gamma-amino-butyric acid, but their exact mechanism for treating PDPH is unclear. A possible mechanism for gabapentin-mediated analgesia is the modulation of glutamate receptors (N-methyl-D-aspartate (NMDA) and α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) /kainite). Also it inhibits nociceptive responses to intrathecal NMDA and AMPA in vivo.

Metadane badania

NCT ID
NCT07916116
Status
Trwa rekrutacja
Faza
PHASE2, PHASE3
Sponsor
Assiut University
Data startu
01.03.2026
Choroby
Postdural Puncture Headache (PDPH)
Kraje
Egypt