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Completed

NCT Number: NCT06790758

Plasma Rich Fibrin Epidural Injection by Racz Catheter in Postdural Puncture Headache Guided Optic Nerve Sheath Diameter

This study aims to evaluate plasma-rich fibrin epidural injection by Racz catheter in post-dural puncture headaches guided optic nerve sheath diameter.

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Key information

Conditions

Plasma Rich Fibrin Brain Diseases Central Nervous System Diseases Epidural Headache Disorders Headache Disorders, Secondary Nervous System Diseases Optic Nerve Sheath Diameter 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

Postdural puncture headaches (PDPHs) are a recognized complication following unintentional dural puncture during epidural analgesia or intentional dural puncture for spinal anesthesia, diagnostic, or interventional neuraxial procedures.

Plasma-rich fibrin (PRF) is derived from autologous whole blood that contains and releases several different growth factors and cytokines to stimulate the healing of bone and soft tissue via degranulation, which has recently gained popularity in pain management.

Optic nerve sheath diameter (ONSD) is important because the optic nerve is surrounded by subarachnoidal cerebrospinal fluid and all three meningeal layers, and a change in the ONSD can indicate changes in intracranial pressure.

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 severe post-dural puncture headache.

Exclusion criteria

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

Treatment and study plan

Plasma rich fibrin epidural injection by Racz catheter

Drug

Patients will receive plasma-rich fibrin epidural injection by Racz catheter in post-dural puncture headache-guided optic nerve sheath diameter.

Primary outcomes

  1. Success rate of the procedure

    Time frame: 24 hours after the intervention

    Success rate plasma-rich fibrin 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

    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 PRF and the efficacy of plasma-rich fibrin 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

    Time frame: 6 hours after the procedure

    Change in optic nerve sheath diameter (ONSD) will be measured before and 6 hours after 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 2, 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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