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

Not Applicable

Recruiting

• Conditions: Plasma Rich Fibrin; Epidural; Racz Catheter; Epidural Blood Patch; Postdural Puncture Headache
• Interventions: Procedure: Epidural blood patch; Drug: Plasma rich fibrin epidural injection by Racz catheter

• Registration Number: NCT06790745
• Lead Sponsor: Tanta University

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Study First Posted: 2025-01-24
• Study Start: 2025-01-25
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural blood patch group	Epidural blood patch	Patients will receive epidural blood patch injection
Plasma rich fibrin epidural injection by Racz catheter group	Plasma rich fibrin epidural injection by Racz catheter	Patients will receive plasma-rich fibrin epidural injection by Racz catheter

Primary Outcome Measures

Name	Time	Method
Success rate of the procedures	24 hours postoperatively	The success rate of techniques for the treatment of headaches and associated symptoms on a 4-point rating scale (0 = none, 1 = slight, 2 = marked, 3 = complete relief) will be recorded.

Secondary Outcome Measures

Name	Time	Method
Degree of pain	8 days postoperatively	The degree of pain will be assessed using the Numeric Rating Scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at (0, 6, 12, 24, 48) h, 3, 4, 5, 6, 7, 8 days postoperatively.
Length of bed rest	8 days postoperatively	Length of bed rest after techniques and the efficacy of techniques for the treatment of headaches and associated symptoms on a 4-point rating scale (0 = none, 1 = slight, 2 = marked, 3 = complete relief) will be recorded.
Change in optic nerve sheath diameter (ONSD)	6 hours the procedure	Optic nerve sheath diameter (ONSD) will be measured before and after 6 hours of the procedure.
Incidence of complications	8 days postoperatively	Incidence of complications that may occur during the technique such as (bending of the tip of the needle, shearing of the catheter, misplacement of the catheter, blocking of the catheter, blood aspiration and bleeding in the epidural space, hypotension, migration of the catheter, paresthesia, headache and infection) will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt