Post-Dural Puncture HeadachePhase 1/2NCT06729047
Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries
A Phase 1/2 study testing normal Saline, Neostigmine and Ketorolac in people with Post-Dural Puncture Headache, run by Assiut University at 1 site in Egypt.
Trial summary
Post-dural puncture headache (PDPH) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- normal Saline, Neostigmine and Ketorolac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 5 Nov 2025
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI less than 35 kg/m2
- Scheduled for infraumbilical surgeries
- American Society of Anesthesiologists (ASA) physical status: I and II
Who cannot join
- ASA physical status more than II.
- History of allrgic response to local anaesthetics or any of the medications used in the study
- Patients with cognitive impairment
- pregnancy
- Basal body temperature of more than 38°C or less than 36°C
- BMI more than 35 kg/m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries: A Randomized Clinical Trial
Post-dural puncture headache (PDPH) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. It usually starts within several hours after spinal anesthesia, but sometimes it can be delayed for up to 2 weeks, which usually resolves within a few days
Read the detailed description
The usual symptoms of PDPH other than headache are photophobia, neck stiffness, nausea and vomiting, diplopia, tinnitus, and dizziness. The headache is usually throbbing and severe, starting from the forehead and extending to the occiput, and is aggravated by standing or sitting. This is due to meningeal traction associated with cerebrospinal fluid (CSF) pressure reduction or dilation of cerebral arteries as an indirect effect of lowering CSF pressure as a result of CSF leakage from the punctured dura. Current treatments or preventive measures for PDPH other than bed rest and hydration include theophylline, sumatriptan, caffeine, etc. In resistant or severe cases, epidural blood patch (EBP) is a well-described technique used to provide relief of pain.
The co-administration of neostigmine and atropine is a common treatment for terminating the effects of non-depolarizing muscle relaxants in the setting of general anesthesia with minimal side
- Conditions
- Post-Dural Puncture Headache
- Being tested
- normal Saline, Neostigmine, Ketorolac
- Keywords
- Neostigmine, ketorolac
- 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.
normal SalineDrug
patients will receive placebo (normal saline)
NeostigmineDrug
patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)
KetorolacDrug
patients will receive ketorolac (0.5 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | patients will receive placebo (normal saline) Receives: Drug: normal Saline |
| Group N | Active comparator | patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg) Receives: Drug: Neostigmine |
| Group K | Active comparator | patients will receive ketorolac (0.5 mg/kg) Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
postdural puncture headache
the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion5 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729047
- Sponsor's protocol ID
- 04-2024-200988
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kamm K, Forderreuther S. [Post-dural puncture headache]. Schmerz. 2021 Apr;35(2):139-149. doi: 10.1007/s00482-021-00540-x. Epub 2021 Mar 16. German.
PubMed 33725180Ljubisavljevic S, Zidverc Trajkovic J. Postdural puncture headache leads to clinical worsening of pre-existing chronic headache. J Clin Neurosci. 2020 May;75:30-34. doi: 10.1016/j.jocn.2020.03.043. Epub 2020 Mar 26.
PubMed 32223975Ahmadzade Z, Golparvar M, Sepiani S. Evaluation of the Preventive Effects of Neostigmine Plus Atropine on Post-Dural Puncture Headache. Adv Biomed Res. 2023 May 15;12:119. doi: 10.4103/abr.abr_81_22. eCollection 2023.
PubMed 37434934
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06729047
- Acronym / sponsor ID
- 04-2024-200988
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Neostigmine, ketorolac
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 5 Nov 2025 (estimated)
- First posted
- 11 Dec 2024 (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) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. It usually starts within several hours after spinal anesthesia, but sometimes it can be delayed for up to 2 weeks, which usually resolves within a few days
Detailed description
The usual symptoms of PDPH other than headache are photophobia, neck stiffness, nausea and vomiting, diplopia, tinnitus, and dizziness. The headache is usually throbbing and severe, starting from the forehead and extending to the occiput, and is aggravated by standing or sitting. This is due to meningeal traction associated with cerebrospinal fluid (CSF) pressure reduction or dilation of cerebral arteries as an indirect effect of lowering CSF pressure as a result of CSF leakage from the punctured dura. Current treatments or preventive measures for PDPH other than bed rest and hydration include theophylline, sumatriptan, caffeine, etc. In resistant or severe cases, epidural blood patch (EBP) is a well-described technique used to provide relief of pain.
The co-administration of neostigmine and atropine is a common treatment for terminating the effects of non-depolarizing muscle relaxants in the setting of general anesthesia with minimal side
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: normal Salinepatients will receive placebo (normal saline) |
| Group N | Active comparator | Drug: Neostigminepatients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg) |
| Group K | Active comparator | Drug: Ketorolacpatients will receive ketorolac (0.5 mg/kg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI less than 35 kg/m2
- Scheduled for infraumbilical surgeries
- American Society of Anesthesiologists (ASA) physical status: I and II
Key exclusion criteria (6 listed)
- ASA physical status more than II.
- History of allrgic response to local anaesthetics or any of the medications used in the study
- Patients with cognitive impairment
- pregnancy
- Basal body temperature of more than 38°C or less than 36°C
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 |
|---|---|---|
| normal Salinepatients will receive placebo (normal saline) | Drug | Group C |
| Neostigminepatients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg) | Drug | Group N |
| Ketorolacpatients will receive ketorolac (0.5 mg/kg) | Drug | Group K |
Primary outcome
postdural puncture headache
Time frame: 1 week
the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.
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 11 Dec 2024.
- Background: PubMed 33725180Kamm K, Forderreuther S. [Post-dural puncture headache]. Schmerz. 2021 Apr;35(2):139-149. doi: 10.1007/s00482-021-00540-x. Epub 2021 Mar 16. German.
- Background: PubMed 32223975Ljubisavljevic S, Zidverc Trajkovic J. Postdural puncture headache leads to clinical worsening of pre-existing chronic headache. J Clin Neurosci. 2020 May;75:30-34. doi: 10.1016/j.jocn.2020.03.043. Epub 2020 Mar 26.
- Background: PubMed 37434934Ahmadzade Z, Golparvar M, Sepiani S. Evaluation of the Preventive Effects of Neostigmine Plus Atropine on Post-Dural Puncture Headache. Adv Biomed Res. 2023 May 15;12:119. doi: 10.4103/abr.abr_81_22. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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 1/2 study testing normal Saline, Neostigmine and Ketorolac in people with Post-Dural Puncture Headache, 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Dec 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ghada Abo Elfadl, MD (01005802086, ghadafadl77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postdural puncture headache (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06729047, which also lists 3 linked publications.
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 11 Dec 2024.