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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | 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 |
|
| Pregabalin | Active Comparator | received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours |
|
| Hydrocortisone | Active Comparator | received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 100Mg Oral Cap | Drug | giving a drug to relieve post-dural puncture headache |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The study group is the pregnant females undergoing cesarean section
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Zamalek | 11586 | Egypt |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D002214 | Capsules |
| D006854 | Hydrocortisone |
| D000082 | Acetaminophen |
| D005440 | Fluid Therapy |
| D002110 | Caffeine |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Hydrocortisone |
| Drug |
Giving drug to relieve post-dural puncture headache |
|
| Acetaminophen | Drug | giving a drug to relieve post-dural puncture headache |
|
|
| oral fluids | Other | giving oral fluids to maintain good hydration |
|
|
| Caffeine | Drug | giving a drug to relieve post-dural puncture headache |
|
| Diclofenac | Drug | giving a drug to relieve post-dural puncture headache |
|
| the first 48 hours following treatment |
| incidence of side effect of the studied drug | incidence of dizziness | the first 48 hours following treatment |
| D009422 | Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |