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

NCT06790758 | Completed

• 1 other identifier: 36264PR940/11/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plasma Rich Fibrin; Epidural; Racz Catheter; Postdural Puncture Headache; Optic Nerve Sheath Diameter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Degree of pain

  8 days postoperatively

• Length of bed rest

  8 days postoperatively

• Change in optic nerve sheath diameter

  6 hours after the procedure

• Incidence of complications

  8 days postoperatively

Study Arms (1)

Plasma rich fibrin epidural injection by Racz catheter

EXPERIMENTAL

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

Interventions

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.

Plasma rich fibrin epidural injection by Racz catheter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• Patients suffering from severe post-dural puncture headache.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: January 25, 2025
• Primary Completion: November 23, 2025
• Study Completion: November 23, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)