Plasma Rich Fibrin Epidural Injection by Racz Catheter Versus Epidural Blood Patch in Postdural Puncture Headache

NCT ID: NCT06790745

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2025-10-30

Brief Summary

This study aims to evaluate plasma-rich fibrin epidural injection by Racz catheter and epidural blood patch in Post dural puncture headache.

Detailed Description

Post-dural puncture headache (PDPH) is also known as post-lumbar puncture (LP). PDPH is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent dural puncture during epidural anesthesia.

Traditional management strategies include conservative measures such as oral analgesia, bed rest, oral or intravenous hydration, oral or intravenous caffeine, and administration of epidural crystalloid before catheter removal, but in refractory cases, more invasive techniques may be necessary. An epidural blood patch (EBP) has been the most favorable treatment for PDPH after an accidental dural puncture.

One innovative approach is the use of plasma-rich fibrin (PRF) derived from autologous whole blood, which contains and releases several different growth factors and cytokines to stimulate the healing of bone and soft tissue via degranulation. This approach has recently gained popularity in pain management. Another is the Racz catheter, a thin and flexible catheter used for targeted delivery of therapeutic agents.

Conditions

Plasma Rich Fibrin; Epidural; Racz Catheter; Epidural Blood Patch; Postdural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epidural blood patch group

Patients will receive epidural blood patch injection

Group Type: EXPERIMENTAL

Epidural blood patch

Intervention Type: PROCEDURE

Patients will receive epidural blood patch injection

Plasma rich fibrin epidural injection by Racz catheter group

Patients will receive plasma-rich fibrin epidural injection by Racz catheter

Group Type: EXPERIMENTAL

Plasma rich fibrin epidural injection by Racz catheter

Intervention Type: DRUG

Patients will receive plasma rich fibrin injection by Racz catheter

Interventions

Epidural blood patch

Patients will receive epidural blood patch injection

Intervention Type: PROCEDURE

Plasma rich fibrin epidural injection by Racz catheter

Patients will receive plasma rich fibrin injection by Racz catheter

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 65 years.
• Both sexes.
• Patients suffering from post-dural puncture headache.

Exclusion Criteria

• Uncooperative patients.
• Severe comorbid conditions.
• Pregnancy.
• Anticoagulant therapy.
• Known allergies to plasma-rich fibrin or epidural blood patch components.
• Body mass index (BMI) ≥35 kg/m2.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR939/11/24

Identifier Type: -

Identifier Source: org_study_id