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.

Study Overview

• Status: Completed
• Conditions: Optic Nerve Sheath Diameter; Epidural; Postdural Puncture Headache; Racz Catheter; Plasma Rich Fibrin
• Intervention / Treatment: Drug: Plasma rich fibrin epidural injection by Racz catheter

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plasma rich fibrin epidural injection by Racz catheter; Patients will receive plasma-rich fibrin epidural injection by Racz catheter in post-dural puncture headache-guided optic nerve sheath diameter.	Drug: Plasma rich fibrin epidural injection by Racz catheter; Patients will receive plasma-rich fibrin epidural injection by Racz catheter in post-dural puncture headache-guided optic nerve sheath diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of the procedure	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.	24 hours after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	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	8 days postoperatively
Length of bed rest	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.	8 days postoperatively
Change in optic nerve sheath diameter	Change in optic nerve sheath diameter (ONSD) will be measured before and 6 hours after the procedure.	6 hours after the procedure
Incidence of complications	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.	8 days postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Actual): November 23, 2025
• Study Completion (Actual): November 23, 2025

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 18, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Post-Dural Puncture Headache
• Other Study ID Numbers: 36264PR940/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No