Pregabalin in Treatment of Postdural Puncture Headache

Al-Azhar University

Status and phase: Completed; Phase 3

Conditions: Postdural Puncture Headache

Treatments: Drug: Pregabalin 75mg; Combination Product: conservative treatment.; Biological: An epidural blood patch (EBP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06271486

RC. 40.5.2023

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Group A (pregabalin group)

Active Comparator group

Description:

Received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.

Treatment:

Drug: Pregabalin 75mg

Group B (EBP group)

Active Comparator group

Description:

Received active therapy in the form of an EBP and Group C (control group) received conservative treatment.

Treatment:

Biological: An epidural blood patch (EBP)

Group C (the control group)

Active Comparator group

Description:

received conservative treatment.

Treatment:

Combination Product: conservative treatment.