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

Not Applicable

Recruiting

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

• Registration Number: NCT06790758
• Lead Sponsor: Tanta University

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Study First Posted: 2025-01-24
• Study Start: 2025-01-25
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plasma rich fibrin epidural injection by Racz catheter	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.

Primary Outcome Measures

Name	Time	Method
Success rate of the procedure	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 Outcome Measures

Name	Time	Method
Degree of pain	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
Length of bed rest	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.
Change in optic nerve sheath diameter	6 hours after the procedure	Change in optic nerve sheath diameter (ONSD) will be measured before and 6 hours after the procedure.
Incidence of complications	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt