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

Tanta University60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Epidural blood patchPROCEDURE

Patients will receive epidural blood patch injection

Plasma rich fibrin epidural injection by Racz catheterDRUG

Patients will receive plasma rich fibrin injection by Racz catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 24 hours postoperatively

Secondary Outcomes

Degree of pain

The 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.

Time frame: 8 days postoperatively

Length of bed rest

Length of bed rest after techniques and the efﬁcacy 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.

Time frame: 8 days postoperatively

Change in optic nerve sheath diameter (ONSD)

Optic nerve sheath diameter (ONSD) will be measured before and after 6 hours of the procedure.

Time frame: 6 hours the procedure

Incidence of complications

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.

Time frame: 8 days postoperatively

Data from ClinicalTrials.gov

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