NCT03080610

Brief Summary

Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice. The investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

9.9 years

First QC Date

March 3, 2017

Last Update Submit

November 26, 2024

Conditions

Post-Dural Puncture Headache

Keywords

Post-Dural Puncture Headache [C10.228.140.546.699.124]Blood Patch, Epidural [E02.319.267.530.580.300.145]

Outcome Measures

Primary Outcomes (1)

  • The Occurrence of Post Dural Puncture Headache after Epidural Blood Patch

    1 year

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch.

You may qualify if:

  • parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch in Siriraj hospital during 1 January 2006 to 30 December 2015

You may not qualify if:

  • patient who diagnosed post Dural puncture headache from accidental Dural puncture from epidural needle or received combine spinal epidural anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pattrapun Wongsripuemtet

Bangkok Noi, Bangkok, 10240, Thailand

Location

Pattrapun Wongsripuemtet

Bangkok, 10240, Thailand

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ladda Permpolprasert, B.N.S

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 15, 2017

Study Start

January 1, 2006

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)