Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section

Conditions
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Post-Dural Puncture Headache

Intervention / Treatment
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* Drug: Pregabalin 100Mg Oral Cap
* Drug: Hydrocortisone
* Drug: Acetaminophen
* Other: oral fluids
* Drug: Caffeine
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>received 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 | Drug: Acetaminophen<br>* giving a drug to relieve post-dural puncture headache<br>* Other names: Paracetamol;Other: oral fluids<br>* giving oral fluids to maintain good hydration<br>* Other names: good hydration;Drug: Caffeine<br>* giving a drug to relieve post-dural puncture headache<br>Drug: Diclofenac<br>* giving a drug to relieve post-dural puncture headache<br>|
| Active Comparator: Pregabalin<br>received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours | Drug: Pregabalin 100Mg Oral Cap<br>* giving a drug to relieve post-dural puncture headache<br>Drug: Acetaminophen<br>* giving a drug to relieve post-dural puncture headache<br>* Other names: Paracetamol;Other: oral fluids<br>* giving oral fluids to maintain good hydration<br>* Other names: good hydration;Drug: Caffeine<br>* giving a drug to relieve post-dural puncture headache<br>Drug: Diclofenac<br>* giving a drug to relieve post-dural puncture headache<br>|
| Active Comparator: Hydrocortisone<br>received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. | Drug: Hydrocortisone<br>* Giving drug to relieve post-dural puncture headache<br>Drug: Acetaminophen<br>* giving a drug to relieve post-dural puncture headache<br>* Other names: Paracetamol;Other: oral fluids<br>* giving oral fluids to maintain good hydration<br>* Other names: good hydration;Drug: Caffeine<br>* giving a drug to relieve post-dural puncture headache<br>Drug: Diclofenac<br>* giving a drug to relieve post-dural puncture headache<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain using Visual Analogue Scale | 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 | the first 48 hours following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the amount of rescue drug | Total dose of nalbuphine given in each group.. | The first 48 hours following treatment | 
| incidence of side effects of the studied drug | incidence of Somnolence | the first 48 hours following treatment | 
| incidence of side effect of the studied drug | incidence of dizziness | the first 48 hours following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal, cesarean, pregabalin