Postdural Puncture Headache (PDPH)Phase 2/3NCT07916116
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
A Phase 2/3 study testing treatment of Postdural puncture headache in people with Postdural Puncture Headache (PDPH), run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postdural Puncture Headache (PDPH)
- What is being tested?
- treatment of Postdural puncture headache
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- hypersensitivity to one of the used drugs.
- liver, kidney, neurological and psychiatric disorders.
- patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University hospital
Asyut, 71111
Mahmoud Adel Faisal, lecturer, 1004391577 ext. 0020, dr_mahmoudfaisal@aun.edu.eg
Sara Mansour, lecturer
About this study
Official title: Beyond the Epidural Blood Patch: Combined Oral Gabapentin and Intravenous Neostigmine/Atropine for Prevention of Post Dural Puncture Headache After Cesarean Section Under Spinal Anaesthesia
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.
Read more
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.
- Conditions
- Postdural Puncture Headache (PDPH)
- Being tested
- treatment of Postdural puncture headache
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of Postdural puncture headacheDrug
using different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | 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 Receives: Drug: treatment of Postdural puncture headache |
| Neostigmine group | Active comparator | 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. Receives: Drug: treatment of Postdural puncture headache |
| Gabapentin group | Active comparator | 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. Receives: Drug: treatment of Postdural puncture headache |
| Neostigmine plus gabapentin group | Active comparator | 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. Receives: Drug: treatment of Postdural puncture headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postdural puncture headache
patients suffering from PDPH after drug treatment
Measured: from enrollment to day 15
Secondary outcomes (3)
Total amount of rescue analgesia
amount of analgesia consumed by patients
Measured: from enrollment to day 15
Severity of PDPH
using NRS (Numerical Rating Scale).
Measured: from enrollment to day 15
Intraoperative complications
nausea, vomiting, tremors, sedation, ataxia, dizziness, bradycardia, hypotension, muscle cramps, muscle twitches, bronchoconstriction, miosis, Increased Secretions
Measured: from enrollment to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture Headache (PDPH)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Faisal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916116
- Sponsor's protocol ID
- anesth35/26
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Epidural Blood Patch: Combined Oral Gabapentin and Intravenous Neostigmine/Atropine for Prevention of Post Dural Puncture Headache After Cesarean Section Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT07916116
- Acronym / sponsor ID
- anesth35/26
- Conditions
- Postdural Puncture Headache (PDPH)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: treatment of Postdural puncture headache73 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 |
| Neostigmine group | Active comparator | Drug: treatment of Postdural puncture headache73 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. |
| Gabapentin group | Active comparator | Drug: treatment of Postdural puncture headache73 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. |
| Neostigmine plus gabapentin group | Active comparator | Drug: treatment of Postdural puncture headache73 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Emergency CS.
- Chronic headache or previous PDPH.
- Any type of chronic pain and those on regular analgesics or anti-epileptic medications.
- Substance abuse.
- Smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment of Postdural puncture headacheusing different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache | Drug | Gabapentin group, Neostigmine group, Neostigmine plus gabapentin group, Placebo group |
Primary outcome
Incidence of postdural puncture headache
Time frame: from enrollment to day 15
patients suffering from PDPH after drug treatment
3 secondary outcomes
Total amount of rescue analgesia
Time frame: from enrollment to day 15
Severity of PDPH
Time frame: from enrollment to day 15
Intraoperative complications
Time frame: from enrollment to day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Postdural Puncture Headache (PDPH)
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Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
Cesarean Section, Postoperative Nausea and Vomiting (PONV)
RecruitingPhase 3
Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
PDPH, Post Dural Puncture Headache
Not yet recruitingObservational study
Ultrasonographic ONSD as a Predictor of PDPH in Spinal Anesthesia for Cesarean Delivery
Cesarean Section Complications
Enrolling by invitationObservational study
Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing treatment of Postdural puncture headache in people with Postdural Puncture Headache (PDPH), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postdural puncture headache (time frame: from enrollment to day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.