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Pregabalin in Treatment of Postdural Puncture Headache

Pregabalin as Alternative to Epidural Blood Patch in Treatment of Postdural Puncture Headache: A Randomized Controlled Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06271486
Enrollment
75
Registered
2024-02-21
Start date
2024-02-28
Completion date
2024-08-15
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postdural Puncture Headache

Brief 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, 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

Interventions

Group A (pregabalin group) received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.

BIOLOGICALAn epidural blood patch (EBP)

Group B (EBP group) received active therapy in the form of an EBP

COMBINATION_PRODUCTconservative 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.

Sponsors

Benha University
CollaboratorOTHER
Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age from 21 to 65 years old, * both genders, * confirmed diagnosis of postdural puncture headache (PDPH)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of complete relief48 hoursThe incidence of complete relief, as reflected in the success rate of the intervention at 48 hours.

Secondary

MeasureTime frameDescription
The intensity of the headache48 hoursThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026