Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Post-Dural Puncture Headache Clinical Trial

— PDPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910088
• Other study ID #: CairoU11112017
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients who underwent elective cesarean section under spinal anesthesia.

• Patients aged 18 to 40 years old.

• Patients classified as ASA I or II.

Exclusion Criteria:

• Patients with known sensitivity to any of the used drugs.

• Patients classified as ASA III or more.

• Preeclampsia.

• Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Pregabalin 100Mg Oral Cap
giving a drug to relieve post-dural puncture headache
• Hydrocortisone
Giving drug to relieve post-dural puncture headache
• 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
• Diclofenac
giving a drug to relieve post-dural puncture headache

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Zamalek

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pain using Visual Analogue Scale	Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment	the first 48 hours following treatment
Secondary	Assessment of the amount of rescue drug	Total dose of nalbuphine given in each group..	The first 48 hours following treatment
Secondary	incidence of side effects of the studied drug	incidence of Somnolence	the first 48 hours following treatment
Secondary	incidence of side effect of the studied drug	incidence of dizziness	the first 48 hours following treatment