Condition category
Nervous System Diseases
Date applied
06/04/2009
Date assigned
27/07/2009
Last edited
27/07/2009
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 Marc Schmittner

ORCID ID

Contact details

Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Correlation of cerebrospinal fluid opening pressure and the incidence of post-dural puncture headache after spinal saddle-block

Acronym

Study hypothesis

The incidence of post-dural puncture headache seems to be associated with cerebrospinal fluid pressure.

Ethics approval

Local medical ethics committee (med. Ethikkommission II; Medizinische Fakultät Mannheim der Ruprechts-Karls-Universität Heidelberg) approved on the 15th December 2008

Study design

Single centre non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-dural puncture headache

Intervention

Using a 27 gauche Quincke needle for spinal anaesthesia in saddle block technique, measuring the cerebrospinal fluid pressure by using a spinal fluid manometer.

All patients were treated according a clincal standard: after dural puncture the dural opening pressure was measured and 1.0 ml cerebrospinal fluid (CSF) preserved. Ambulatory patients receive 1.0 ml scandicaine 4% hyperbaric; in house patients receive 1.0 ml bucaine 0.5% hyperbaric; all patients received a telephone-call 1 week after surgical intervention to obtain information about complications concerning the spinal anaesthesia.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Post-dural puncture headache and other complications within 7 days.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/04/2009

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male/female patients with minor perianal surgery
2. Aged 18 - 80 years
3. American Society of Anaesthesioloists (ASA) grade I - III
4. No contraindications for spinal anaesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Contraindications for spinal anaesthesia
2. Allergy to local anaesthetics

Recruitment start date

15/04/2009

Recruitment end date

01/09/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Sponsor information

Organisation

B. Braun Melsungen AG (Germany)

Sponsor details

Carl-Braun-Strasse 1
Melsungen
34212
Germany

Sponsor type

Industry

Website

http://www.bbraun.com/

Funders

Funder type

Industry

Funder name

B. Braun Melsungen AG (Germany) - provided spinal needles and equipment

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

Publication citations

Additional files

Editorial Notes