NCT03910088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

April 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

April 2, 2019

Last Update Submit

November 7, 2019

Conditions

Post-Dural Puncture Headache

Keywords

spinalcesareanpregabalin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Assessment of the amount of rescue drug

    The first 48 hours following treatment

  • incidence of side effects of the studied drug

    the first 48 hours following treatment

  • incidence of side effect of the studied drug

    the first 48 hours following treatment

Study Arms (3)

control group

PLACEBO COMPARATOR

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: AcetaminophenOther: oral fluidsDrug: CaffeineDrug: Diclofenac

Pregabalin

ACTIVE COMPARATOR

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

Drug: Pregabalin 100Mg Oral CapDrug: AcetaminophenOther: oral fluidsDrug: CaffeineDrug: Diclofenac

Hydrocortisone

ACTIVE COMPARATOR

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

Drug: HydrocortisoneDrug: AcetaminophenOther: oral fluidsDrug: CaffeineDrug: Diclofenac

Interventions

Pregabalin 100Mg Oral CapDRUG

giving a drug to relieve post-dural puncture headache

Pregabalin
HydrocortisoneDRUG

Giving drug to relieve post-dural puncture headache

Hydrocortisone
AcetaminophenDRUG

giving a drug to relieve post-dural puncture headache

Also known as: Paracetamol
HydrocortisonePregabalincontrol group
oral fluidsOTHER

giving oral fluids to maintain good hydration

Also known as: good hydration
HydrocortisonePregabalincontrol group
CaffeineDRUG

giving a drug to relieve post-dural puncture headache

HydrocortisonePregabalincontrol group
DiclofenacDRUG

giving a drug to relieve post-dural puncture headache

HydrocortisonePregabalincontrol group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study group is the pregnant females undergoing cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who underwent elective cesarean section under spinal anesthesia.
  • Patients aged 18 to 40 years old.
  • Patients classified as ASA I or II.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Zamalek, 11586, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

PregabalinCapsulesHydrocortisoneAcetaminophenFluid TherapyCaffeineDiclofenac

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsDosage FormsPharmaceutical PreparationsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsAcetanilidesAnilidesAmidesAniline CompoundsAminesDrug TherapyTherapeuticsXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenylacetatesAcids, Carbocyclic

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 10, 2019

Study Start

April 20, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)