Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Study Overview
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Brief Summary
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Postdural puncture headache (PDPH) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. Symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms. This study will examine the efficacy of mirtazapine in in the treatment of PDPH after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.

Official Title
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Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache Following Obstetric Surgery Under Spinal Anesthesia: A Randomized Controlled Trial

Conditions
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Headache

Intervention / Treatment
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* Drug: Mirtazapine
* Drug: Sumatriptan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II Patients. Patients undergoing obstetric surgeries under spinal anesthesia. and complaining from moderate-to-severe PDPH after 25G or 27G spinal needle puncture. Exclusion Criteria: Refusal of the intervention or participation in the study. Patient under age of 18 years old. Psychiatric illness. Patients with a history of ischemic heart disease, pregnancy-induced hypertension, chronic hypertension, cardiac, vascular, liver or renal impairment. Patients with a history of migraine. Patients with known hypersensitivity to study drugs. Patients currently using ergotamine, monoamine oxidase inhibitors, or selective serotonin reuptake inhibitors.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirtazapine Therapy group (M group)<br> | Drug: Mirtazapine<br>* Mirtazapine 30 mg tablet once daily for 3 successive days<br>|
| Active Comparator: Sumatriptan Therapy group (S group)<br> | Drug: Sumatriptan<br>* Sumatriptan 50 mg tablet once daily for 3 successive days<br>|
| Placebo Comparator: Control group ( C group)<br> | Other: Placebo<br>* Placebo tablets once daily for 3 successive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours | Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours after intervention (Day 0) | 72 hours after intervention (Day 0) |