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Recruiting NCT07916116

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

Conditions: Postdural Puncture Headache (PDPH)

Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 292
Sponsor: Assiut University

Location: Assiut University hospital Asyut

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Scheduled for elective CS under spinal anesthesia. * BMI between 25 and 35 kg/m2. * ASA 11 primigravida or multigravida. * Pregnant in a single full-term fetus. Exclusion Criteria: * Emergency CS. * Chronic headache or previous PDPH. * Any type of chronic pain and those on regular analgesics or anti-epileptic medications. * Substance abuse. * Smoking. * Chronic or gestational hypertension. * hypersensitivity to one of the used drugs. * liver, kidney, neurological and psychiatric disorders. * patient refusal

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07916116). StuddyBuddy aggregates publicly available trial information.