NCT02150304

Brief Summary

postdural puncture headache is a rare but serious complication of spinal anesthesia. many drugs were studied in prevention or treatment of that complication. However, there are limited numbers of trials about intravenous aminophylline for prevention. because of that we retrospectively aimed to investigate the effectiveness of aminophylline for postdural puncture headache in cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

May 24, 2014

Last Update Submit

August 4, 2015

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • postdural puncture headache

    postoperative 2 weeks

Study Arms (2)

intravenous aminophylline

intravenous aminophylline use during spinal anesthesia

no intravenous aminophylline

no use of intravenous aminophylline during spinal anesthesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patient records form who experinced headache after caserean section with spinal anesthesia were retrospectively evaluated

You may qualify if:

  • patients aolder than 18 years old

You may not qualify if:

  • conversion to general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dışkapı Yıldırım Beyazıt Education and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (2)

  • Naghibi K, Hamidi M. Prophylactic administration of aminophylline plus dexamethasone reduces post-dural puncture headache better than using either drug alone in patients undergoing lower extremity surgery. Adv Biomed Res. 2014 Jan 9;3:5. doi: 10.4103/2277-9175.124631. eCollection 2014.

    PMID: 24600595BACKGROUND

  • Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.

    PMID: 23450533BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • ibrahim öztürk, M.D.

    dışkapı yıldırım beyazıt education and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 24, 2014

First Posted

May 29, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

TU(1)