Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2024-02-28
2024-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Pregabalin on Immediate Post-operative and Longterm Pain
NCT02464813
Prophylactic Pregabalin Treatment Following Spinal Cord Injury
NCT06066918
To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
NCT00141375
Management of Pain Associated With Failed Back Surgery Syndrome
NCT05324761
Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
NCT00978341
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A (pregabalin group)
Received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.
Pregabalin 75mg
Group A (pregabalin group) received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.
Group B (EBP group)
Received active therapy in the form of an EBP and Group C (control group) received conservative treatment.
An epidural blood patch (EBP)
Group B (EBP group) received active therapy in the form of an EBP
Group C (the control group)
received conservative treatment.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pregabalin 75mg
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)
Group B (EBP group) received active therapy in the form of an EBP
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* both genders,
* confirmed diagnosis of postdural puncture headache (PDPH)
Exclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Benha University
OTHER
Al-Azhar University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neveen Kohaf
Tanta, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC. 40.5.2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.