Pregabalin in Treatment of Postdural Puncture Headache

Phase 3

Recruiting

• Conditions: Postdural Puncture Headache
• Interventions: Biological: An epidural blood patch (EBP); Combination Product: conservative treatment.; Drug: Pregabalin 75mg

• Registration Number: NCT06271486
• Lead Sponsor: Al-Azhar University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Study Start: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (EBP group)	An epidural blood patch (EBP)	Received active therapy in the form of an EBP and Group C (control group) received conservative treatment.
Group C (the control group)	conservative treatment.	received conservative treatment.
Group A (pregabalin group)	Pregabalin 75mg	Received oral pregabalin treatment administered at 150 mg daily, with 75 mg given every 12 hours.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The intensity of the headache	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.

Trial Locations

Locations (1)

Neveen Kohaf; 🇪🇬 Tanta, Egypt