NCT04662125

Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin

Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	caffeine, 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.
DRUG	Oral prednisolone	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. .
DRUG	oral pregabalin	patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.

Timeline

• Start date: 2020-12-10
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2020-12-10
• Last updated: 2023-11-01

Locations

1 site across 1 country: Egypt