Pregabalin in Treatment of Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271486
• Other study ID #: RC. 40.5.2023
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: March 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

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

Biological:
• An epidural blood patch (EBP)
Group B (EBP group) received active therapy in the form of an EBP

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.

Locations

Country	Name	City	State
Egypt	Neveen Kohaf	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The intensity of the headache	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