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NCT Number: NCT03910088

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

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.

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Zamalek, 11586, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin 100Mg Oral Cap

Drug

giving a drug to relieve post-dural puncture headache

Hydrocortisone

Drug

Giving drug to relieve post-dural puncture headache

Acetaminophen

Drug

giving a drug to relieve post-dural puncture headache

Other names: Paracetamol

oral fluids

Other

giving oral fluids to maintain good hydration

Other names: good hydration

Caffeine

Drug

giving a drug to relieve post-dural puncture headache

Diclofenac

Drug

giving a drug to relieve post-dural puncture headache

Primary outcomes

  1. Assessment of pain using Visual Analogue Scale

    Time frame: the first 48 hours following treatment

    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

Secondary outcomes

  1. Assessment of the amount of rescue drug

    Time frame: The first 48 hours following treatment

    Total dose of nalbuphine given in each group..

  2. incidence of side effects of the studied drug

    Time frame: the first 48 hours following treatment

    incidence of Somnolence

  3. incidence of side effect of the studied drug

    Time frame: the first 48 hours following treatment

    incidence of dizziness

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: PDPH

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2019
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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