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OpenTrials
Completed

NCT Number: NCT06271486

Pregabalin in Treatment of Postdural Puncture Headache

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

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neveen Kohaf

Tanta, 11865, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin 75mg

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The intensity of the headache

    Time frame: 48 hours

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Benha University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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