Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean (PDPH)

November 7, 2019 updated by: Nesrine El-Refai, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Zamalek
      • Cairo, Zamalek, Egypt, 11586
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
received 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
Drug: Acetaminophen
giving a drug to relieve post-dural puncture headache
Other Names:
  • Paracetamol
Other: oral fluids
giving oral fluids to maintain good hydration
Other Names:
  • good hydration
Drug: Caffeine
giving a drug to relieve post-dural puncture headache
Drug: Diclofenac
giving a drug to relieve post-dural puncture headache
Active Comparator: Pregabalin
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
Drug: Acetaminophen
giving a drug to relieve post-dural puncture headache
Other Names:
  • Paracetamol
Other: oral fluids
giving oral fluids to maintain good hydration
Other Names:
  • good hydration
Drug: Caffeine
giving a drug to relieve post-dural puncture headache
Drug: Diclofenac
giving a drug to relieve post-dural puncture headache
Drug: Pregabalin 100Mg Oral Cap
giving a drug to relieve post-dural puncture headache
Active Comparator: Hydrocortisone
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
Drug: Acetaminophen
giving a drug to relieve post-dural puncture headache
Other Names:
  • Paracetamol
Other: oral fluids
giving oral fluids to maintain good hydration
Other Names:
  • good hydration
Drug: Caffeine
giving a drug to relieve post-dural puncture headache
Drug: Diclofenac
giving a drug to relieve post-dural puncture headache
Drug: Hydrocortisone
Giving drug to relieve post-dural puncture headache

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the first 48 hours following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the amount of rescue drug
Time Frame: The first 48 hours following treatment
Total dose of nalbuphine given in each group..
The first 48 hours following treatment
incidence of side effects of the studied drug
Time Frame: the first 48 hours following treatment
incidence of Somnolence
the first 48 hours following treatment
incidence of side effect of the studied drug
Time Frame: the first 48 hours following treatment
incidence of dizziness
the first 48 hours following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoU11112017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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