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NCT Number: NCT06790745

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

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

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Key information

Conditions

Plasma Rich Fibrin Brain Diseases Central Nervous System Diseases Epidural Epidural Blood Patch Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache Postdural Puncture Headache Racz Catheter

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural Blood Patch

Procedure

Patients will receive epidural blood patch injection

Plasma rich fibrin epidural injection by Racz catheter

Drug

Patients will receive plasma rich fibrin injection by Racz catheter

Primary outcomes

  1. Success rate of the procedures

    Time frame: 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 outcomes

  1. Degree of pain

    Time frame: 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.

  2. Length of bed rest

    Time frame: 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.

  3. Change in optic nerve sheath diameter (ONSD)

    Time frame: 6 hours the procedure

    Optic nerve sheath diameter (ONSD) will be measured before and after 6 hours of the procedure.

  4. Incidence of complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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