Comparing two treatments for headaches after spinal anesthesia
Plasma Rich Fibrin Epidural Injection by Racz Catheter Versus Epidural Blood Patch in Postdural Puncture Headache
This study is testing whether a new treatment using plasma-rich fibrin injections is better than the traditional blood patch for helping people who have headaches after spinal anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06790745 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of plasma-rich fibrin epidural injection using a Racz catheter versus the traditional epidural blood patch for treating post-dural puncture headache (PDPH). PDPH can occur after spinal anesthesia and is often managed with conservative measures, but this study explores more invasive options for patients who do not respond to standard treatments. The innovative use of plasma-rich fibrin aims to promote healing through growth factors, while the Racz catheter allows for precise delivery of the treatment. The goal is to determine which method provides better relief for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are experiencing post-dural puncture headaches.
Not a fit: Patients with severe comorbid conditions, pregnancy, or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from post-dural puncture headaches.
How similar studies have performed: While traditional methods like the epidural blood patch have been widely used, the use of plasma-rich fibrin in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 65 years. * Both sexes. * Patients suffering from post-dural puncture headache. Exclusion Criteria: * 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.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.