A Phase 2/3 interventional study of treatment of Postdural puncture headache in Postdural Puncture Headache (PDPH), sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Assiut University · Phase 2/3, Interventional, and Treatment
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.
131 studies on the registry are indexed under Post-Dural Puncture Headache; 29 are open to participants now.
This study's planned enrollment of 292 is above the median of 80 across 87 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Assiut University is the lead sponsor of 5,068 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
73 participants will receive 10 ml normal saline after fetal delivery + oral placebo tablet by small sip of water 2 hours before admission to the operating room
Drug: treatment of Postdural puncture headache
73 participants will receive (20 μg/kg neostigmine + atropine 0.02 mg / kg) diluted in 10 ml saline after fetal delivery + oral placebo tablet by small sip of water 2 hours before admission to the operating room.
Drug: treatment of Postdural puncture headache
73 participants will receive 10 ml saline after fetal delivery + oral Gabapentin 600 mg by small sip of water 2 hours before admission to the operating room.
Drug: treatment of Postdural puncture headache
73 participants will receive (20 μg/kg neostigmine+ atropine 0.02 mg / kg) diluted in 10 ml saline after fetal delivery +oral Gabapentin 600 mg by small sip of water 2 hours before admission to the operating room.
Drug: treatment of Postdural puncture headache
using different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache
Incidence of postdural puncture headache
patients suffering from PDPH after drug treatment
Time frame: from enrollment to day 15
Total amount of rescue analgesia
amount of analgesia consumed by patients
Time frame: from enrollment to day 15
Severity of PDPH
using NRS (Numerical Rating Scale).
Time frame: from enrollment to day 15
Intraoperative complications
nausea, vomiting, tremors, sedation, ataxia, dizziness, bradycardia, hypotension, muscle cramps, muscle twitches, bronchoconstriction, miosis, Increased Secretions
Time frame: from enrollment to day 15
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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