Pregabalin in Treatment of Postdural Puncture Headache

June 14, 2025 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 11865
        • Neveen Kohaf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (pregabalin group)
Received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.
Drug: Pregabalin 75mg
Group A (pregabalin group) received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.
Active Comparator: Group B (EBP group)
Received active therapy in the form of an EBP and Group C (control group) received conservative treatment.
Biological: An epidural blood patch (EBP)
Group B (EBP group) received active therapy in the form of an EBP
Active Comparator: Group C (the control group)
received conservative treatment.
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Collaborators

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 14, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC. 40.5.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon reasonable request from corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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