Clinical Trials Directory

Trials / Completed

CompletedNCT06790745

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This study aims to evaluate plasma-rich fibrin epidural injection by Racz catheter and epidural blood patch in Post dural puncture headache.

Detailed description

Post-dural puncture headache (PDPH) is also known as post-lumbar puncture (LP). PDPH is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent dural puncture during epidural anesthesia. Traditional management strategies include conservative measures such as oral analgesia, bed rest, oral or intravenous hydration, oral or intravenous caffeine, and administration of epidural crystalloid before catheter removal, but in refractory cases, more invasive techniques may be necessary. An epidural blood patch (EBP) has been the most favorable treatment for PDPH after an accidental dural puncture. One innovative approach is the use of plasma-rich fibrin (PRF) derived from autologous whole blood, which contains and releases several different growth factors and cytokines to stimulate the healing of bone and soft tissue via degranulation. This approach has recently gained popularity in pain management. Another is the Racz catheter, a thin and flexible catheter used for targeted delivery of therapeutic agents.

Conditions

Interventions

TypeNameDescription
PROCEDUREEpidural blood patchPatients will receive epidural blood patch injection
DRUGPlasma rich fibrin epidural injection by Racz catheterPatients will receive plasma rich fibrin injection by Racz catheter

Timeline

Start date
2025-01-25
Primary completion
2025-10-30
Completion
2025-10-30
First posted
2025-01-24
Last updated
2025-12-09

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06790745. Inclusion in this directory is not an endorsement.