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

Primary Purpose

Post-Dural Puncture Headache

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin 100Mg Oral Cap
Hydrocortisone
Acetaminophen
oral fluids
Caffeine
Diclofenac
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache focused on measuring spinal, cesarean, pregabalin

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control group

Pregabalin

Hydrocortisone

Arm Description

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

received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours

received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of the amount of rescue drug
Total dose of nalbuphine given in each group..
incidence of side effects of the studied drug
incidence of Somnolence
incidence of side effect of the studied drug
incidence of dizziness

Full Information

First Posted
April 2, 2019
Last Updated
November 7, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03910088
Brief Title
Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean
Acronym
PDPH
Official Title
Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
Keywords
spinal, cesarean, pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours
Arm Title
Hydrocortisone
Arm Type
Active Comparator
Arm Description
received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 100Mg Oral Cap
Intervention Description
giving a drug to relieve post-dural puncture headache
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Giving drug to relieve post-dural puncture headache
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Paracetamol
Intervention Description
giving a drug to relieve post-dural puncture headache
Intervention Type
Other
Intervention Name(s)
oral fluids
Other Intervention Name(s)
good hydration
Intervention Description
giving oral fluids to maintain good hydration
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
giving a drug to relieve post-dural puncture headache
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
giving a drug to relieve post-dural puncture headache
Primary Outcome Measure Information:
Title
Assessment of pain using Visual Analogue Scale
Description
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
Time Frame
the first 48 hours following treatment
Secondary Outcome Measure Information:
Title
Assessment of the amount of rescue drug
Description
Total dose of nalbuphine given in each group..
Time Frame
The first 48 hours following treatment
Title
incidence of side effects of the studied drug
Description
incidence of Somnolence
Time Frame
the first 48 hours following treatment
Title
incidence of side effect of the studied drug
Description
incidence of dizziness
Time Frame
the first 48 hours following treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study group is the pregnant females undergoing cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Zamalek
ZIP/Postal Code
11586
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

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