Pregabalin in Treatment of Postdural Puncture Headache

NCT06271486 | Completed Phase 3

• 1 other identifier: RC. 40.5.2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• the incidence of complete relief

  The incidence of complete relief, as reflected in the success rate of the intervention at 48 hours.

  48 hours

Secondary Outcomes (1)

• The intensity of the headache

  48 hours

Study Arms (3)

Group A (pregabalin group)

ACTIVE COMPARATOR

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

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.

Biological: An epidural blood patch (EBP)

Group C (the control group)

ACTIVE COMPARATOR

received conservative treatment.

Combination Product: conservative treatment.

Interventions

Pregabalin 75mg DRUG

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

Group A (pregabalin group)

An epidural blood patch (EBP) BIOLOGICAL

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

Group B (EBP group)

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.

Group C (the control group)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (1)

Neveen Kohaf

Tanta, 11865, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Pregabalin; Conservative Treatment

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: February 28, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)