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

NCT06790745 | Completed

• 1 other identifier: 36264PR939/11/24
• 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 and epidural blood patch in Post dural puncture headache.

Conditions

Plasma Rich Fibrin; Epidural; Epidural Blood Patch; Racz Catheter; Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Success rate of the procedures

  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.

  24 hours postoperatively

Secondary Outcomes (4)

• Degree of pain

  8 days postoperatively

• Length of bed rest

  8 days postoperatively

• Change in optic nerve sheath diameter (ONSD)

  6 hours the procedure

• Incidence of complications

  8 days postoperatively

Study Arms (2)

Epidural blood patch group

EXPERIMENTAL

Patients will receive epidural blood patch injection

Procedure: Epidural blood patch

Plasma rich fibrin epidural injection by Racz catheter group

EXPERIMENTAL

Patients will receive plasma-rich fibrin epidural injection by Racz catheter

Drug: Plasma rich fibrin epidural injection by Racz catheter

Interventions

Epidural blood patch PROCEDURE

Patients will receive epidural blood patch injection

Epidural blood patch group

Plasma rich fibrin epidural injection by Racz catheter DRUG

Patients will receive plasma rich fibrin injection by Racz catheter

Plasma rich fibrin epidural injection by Racz catheter group

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 post-dural puncture headache.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Blood Patch, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

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)