Post-Dural Puncture Headache
Conditions
Keywords
spinal, cesarean, pregabalin
Brief summary
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.
Detailed description
The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.
Interventions
DRUGPregabalin 100Mg Oral Cap
giving a drug to relieve post-dural puncture headache
DRUGHydrocortisone
Giving drug to relieve post-dural puncture headache
DRUGAcetaminophen
giving a drug to relieve post-dural puncture headache
OTHERoral fluids
giving oral fluids to maintain good hydration
DRUGCaffeine
giving a drug to relieve post-dural puncture headache
DRUGDiclofenac
giving a drug to relieve post-dural puncture headache
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients who underwent elective cesarean section under spinal anesthesia. * Patients aged 18 to 40 years old. * Patients classified as ASA I or II.
Exclusion criteria
* Patients with known sensitivity to any of the used drugs. * Patients classified as ASA III or more. * Preeclampsia. * Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pain using Visual Analogue Scale | the first 48 hours following treatment | Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the amount of rescue drug | The first 48 hours following treatment | Total dose of nalbuphine given in each group.. |
| incidence of side effects of the studied drug | the first 48 hours following treatment | incidence of Somnolence |
| incidence of side effect of the studied drug | the first 48 hours following treatment | incidence of dizziness |
Countries
Egypt
Outcome results
None listed