NCT03910088

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Post-Dural Puncture Headache

Interventions

Type	Name	Description
DRUG	Pregabalin 100Mg Oral Cap	giving a drug to relieve post-dural puncture headache
DRUG	Hydrocortisone	Giving drug to relieve post-dural puncture headache
DRUG	Acetaminophen	giving a drug to relieve post-dural puncture headache
OTHER	oral fluids	giving oral fluids to maintain good hydration
DRUG	Caffeine	giving a drug to relieve post-dural puncture headache
DRUG	Diclofenac	giving a drug to relieve post-dural puncture headache

Timeline

• Start date: 2019-04-20
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2019-04-10
• Last updated: 2019-11-12

Locations

1 site across 1 country: Egypt