Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin
Study Details
Study Description
Brief Summary
The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.
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To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups.
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To detect any side effects of the study medications in all patient groups.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: group A Group A (conservative treatment): Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener. |
Drug: caffeine, paracetamol tablet
Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.
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Active Comparator: group B Group B (oral prednisolone): Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days. |
Drug: Oral prednisolone
Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.
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Active Comparator: group C Group C (oral pregabalin): Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days. |
Drug: oral Pregabalin
Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.
Other Names:
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Outcome Measures
Primary Outcome Measures
- pain intensity of headache [From onset of the headache (0 hour).]
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
- pain intensity of headache [at 12 hours]
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
- pain intensity of headache [at 24 hours]
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
- pain intensity of headache [at 48 hours]
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
- pain intensity of headache [at 72 hours]
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
- Total dose of rescue analgesia (ketorolac) consumption [from the onset of headache till 72 hours]
total consumption of rescue analgesia (ketorolac) from the onset of headache till 72 hours
- time of relieve of Post dural puncture headache [from the onset of headache till 72 hours]
time from start treatment till relieve symptoms
Secondary Outcome Measures
- The number of participant with nausea, vomiting, diplopia, dizziness and neck stiffness [for 72 hours]
The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness
- Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness [for 72 hours]
In case of sedation, the level will be assessed by using Ramsay Sedation Score (1= anxious or agitated, 2= cooperative and oriented, 3= responds to commands only and 4= brisk response to light tap or loud auditory stimulus)
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Both gender.
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Age: 18- 50 years old.
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American Society of Anesthesiologist (ASA) physical status I - II.
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Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .
Exclusion Criteria:
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- Allergy to study drugs.
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History of chronic headache and migraine.
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History of cerebrovascular accidents and neurological disorders.
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Systemic infection
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History of uncontrolled DM or hepatic disease or pregnant female
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Patient refusal or uncooperative patient.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | faculty of medicine, Zagazig university | Zagazig | Egypt |
Sponsors and Collaborators
- Zagazig University
Investigators
- Principal Investigator: Dina Salem, MD, faculty of medicine , Zagazig university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6324