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

Tanta University

Status: Enrolling

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

Treatments: Procedure: Epidural blood patch; Drug: Plasma rich fibrin epidural injection by Racz catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06790745

36264PR939/11/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Epidural blood patch group

Experimental group

Description:

Patients will receive epidural blood patch injection

Treatment:

Procedure: Epidural blood patch

Plasma rich fibrin epidural injection by Racz catheter group

Experimental group

Description:

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

Treatment:

Drug: Plasma rich fibrin epidural injection by Racz catheter