Condition category
Surgery
Date applied
28/04/2005
Date assigned
18/05/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Diederik WJ Dippel

ORCID ID

Contact details

Erasmus Medical Centre
PO Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 408 7979
d.dippel@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BLOPP

Study hypothesis

The purpose of the study is to assess the effect of an epidural blood on postpunctional headache after a diagnostic lumbar puncture (the formal hypothesis would be that there is no effect on postpunctional headache).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post Lumbar Puncture Headache

Intervention

Blood patch versus conservative treatment

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Presence of postpunctional headache at 24 hours after inclusion in the study

Secondary outcome measures

1. Presence of postpunctional headache at 7 days
2. The number of days until headache subsides

Overall trial start date

01/01/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with postpunctional headache after a diagnostic lumbar puncture

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Netherlands Headache Society (Nederlandse Hoofdpijn Vereniging) (The Netherlands)

Sponsor details

Schubertlaan 11
Breda
4837 CP
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Headache Society (Nederlandse Hoofdpijn Vereniging) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15998467
2. http://www.ncbi.nlm.nih.gov/pubmed/17635971

Publication citations

  1. Oedit R, van Kooten F, Bakker SL, Dippel DW, Efficacy of the epidural blood patch for the treatment of post lumbar puncture headache BLOPP: a randomised, observer-blind, controlled clinical trial [ISRCTN 71598245]., BMC Neurol, 2005, 5, 1, 12, doi: 10.1186/1471-2377-5-12.

  2. van Kooten F, Oedit R, Bakker SL, Dippel DW, Epidural blood patch in post dural puncture headache: a randomised, observer-blind, controlled clinical trial., J. Neurol. Neurosurg. Psychiatr., 2008, 79, 5, 553-558, doi: 10.1136/jnnp.2007.122879.

Additional files

Editorial Notes