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

Tanta University

Status: Enrolling

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

Treatments: Drug: Plasma rich fibrin epidural injection by Racz catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06790758

36264PR940/11/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Plasma rich fibrin epidural injection by Racz catheter

Experimental group

Description:

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

Treatment:

Drug: Plasma rich fibrin epidural injection by Racz catheter