Postdural Puncture HeadachePhase 3NCT06271486
Pregabalin in Treatment of Postdural Puncture Headache
A Phase 3 study testing Pregabalin 75mg, An epidural blood patch (EBP) and conservative treatment. in people with Postdural Puncture Headache, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Pregabalin 75mg, An epidural blood patch (EBP) and conservative treatment.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2024to 15 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 21 to 65 years old,
- both genders,
- confirmed diagnosis of postdural puncture headache (PDPH)
Who cannot join
- patient refusal
- known allergy to the drug used in the study
- patients with a history of convulsions
- chronic headaches
- contraindications to regional anesthesia (such as local infection and coagulation abnormalities).
- Clinical indications of elevated intracranial pressure or associated risk factors
- Deteriorated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregabalin as Alternative to Epidural Blood Patch in Treatment of Postdural Puncture Headache: A Randomized Controlled Clinical Trial
Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders
- Conditions
- Postdural Puncture Headache
- Being tested
- Pregabalin 75mg, An epidural blood patch (EBP), conservative treatment.
- 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.
Pregabalin 75mgDrug
Group A (pregabalin group) received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.
An epidural blood patch (EBP)Biological
Group B (EBP group) received active therapy in the form of an EBP
conservative treatment.Combination product
Group C (control group) received conservative treatment providing recommendations to the patients, including 24 hours of bed rest, stool softener, and consuming a minimum of 2.0 liters of fluid daily. Analgesics were permitted for pain relief depending on the patient's disease status.
| Study group | Role | What they receive |
|---|---|---|
| Group A (pregabalin group) | Active comparator | Received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours. Receives: Drug: Pregabalin 75mg |
| Group B (EBP group) | Active comparator | Received active therapy in the form of an EBP and Group C (control group) received conservative treatment. Receives: Biological: An epidural blood patch (EBP) |
| Group C (the control group) | Active comparator | received conservative treatment. Receives: Combination Product: conservative treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of complete relief
The incidence of complete relief, as reflected in the success rate of the intervention at 48 hours.
Measured: 48 hours
Secondary outcomes (1)
The intensity of the headache
The intensity of the headache was measured using visual analogue score (VAS). The scale uses a scoring system in which values of 0, 1-3, 4-6, and 7-10 correspond, respectively, to the absence of pain, mild, moderate, and severe pain.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start28 Feb 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271486
- Sponsor's protocol ID
- RC. 40.5.2023
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request from corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin as Alternative to Epidural Blood Patch in Treatment of Postdural Puncture Headache: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06271486
- Acronym / sponsor ID
- RC. 40.5.2023
- Conditions
- Postdural Puncture Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 21 Feb 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.
Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (pregabalin group) | Active comparator | Drug: Pregabalin 75mgReceived oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours. |
| Group B (EBP group) | Active comparator | Biological: An epidural blood patch (EBP)Received active therapy in the form of an EBP and Group C (control group) received conservative treatment. |
| Group C (the control group) | Active comparator | Combination Product: conservative treatment.received conservative treatment. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 21 to 65 years old,
- both genders,
- confirmed diagnosis of postdural puncture headache (PDPH)
Key exclusion criteria (7 listed)
- patient refusal
- known allergy to the drug used in the study
- patients with a history of convulsions
- chronic headaches
- contraindications to regional anesthesia (such as local infection and coagulation abnormalities).
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 |
|---|---|---|
| Pregabalin 75mgGroup A (pregabalin group) received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours. | Drug | Group A (pregabalin group) |
| An epidural blood patch (EBP)Group B (EBP group) received active therapy in the form of an EBP | Biological | Group B (EBP group) |
| conservative treatment.Group C (control group) received conservative treatment providing recommendations to the patients, including 24 hours of bed rest, stool softener, and consuming a minimum of 2.0 liters of fluid daily. Analgesics were permitted for pain relief depending on the patient's disease status. | Combination product | Group C (the control group) |
Primary outcome
the incidence of complete relief
Time frame: 48 hours
The incidence of complete relief, as reflected in the success rate of the intervention at 48 hours.
1 secondary outcome
The intensity of the headache
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request from corresponding author
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin 75mg, An epidural blood patch (EBP) and conservative treatment. in people with Postdural Puncture Headache, run by Al-Azhar 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 7 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: finished, as of the sponsor's last update on 18 Jun 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of complete relief (time frame: 48 hours). 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 18 Jun 2025.