Plasma Rich Fibrin, Epidural, Racz Catheter, Postdural Puncture Headache, Optic Nerve Sheath Diameter
Conditions
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.
Interventions
Patients will receive plasma-rich fibrin epidural injection by Racz catheter in post-dural puncture headache-guided optic nerve sheath diameter.
Sponsors
Tanta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed