Analgesia
Conditions
Keywords
oral prednisolone, oral pregabalin, post dural puncture headache (PDPH), lower limb surgeries
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.
Detailed description
1. To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries. 2. To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups. 3. To detect any side effects of the study medications in all patient groups.
Interventions
DRUGcaffeine, paracetamol tablet
oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days.
patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. .
DRUGoral pregabalin
patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
anesthetist not sharing in the study will assess patient
Intervention model description
Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* \- Both gender. * Age: 18- 65 years old. * Body Mass Index 20-30 kg/m2 * American Society of Anesthesiologist (ASA) physical status I - II. * Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .
Exclusion criteria
* \- Allergy to study drugs. * History of chronic headache and migraine. * History of cerebrovascular accidents and neurological disorders. * Systemic infection * History of uncontrolled DM or hepatic disease or pregnant female * Patient refusal or uncooperative patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Headache intensity | From onset of the headache (0 hour). | modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Associated symptoms of post dural puncture headache | 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) |
| total dose of rescue analgesia | for 72 hours | total amount of ketorolac |
Countries
Egypt
Outcome results
None listed