Condition category
Nervous System Diseases
Date applied
22/02/2009
Date assigned
26/05/2009
Last edited
26/05/2009
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 D Schmittner

ORCID ID

Contact details

Universitätsmedizin Mannheim
Klinik für Anästhesiologie und Operative Intensivmedizin
Theodor-Kutzer-Ufer 1-3
Mannheim
69167
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of 27G-Quincke® vs 27G-Pencil-Point® spinal needles and 10 vs 30 minutes fixation time for spinal saddle block regarding the incidence of post-dural puncture headache

Acronym

Study hypothesis

The incidence of post-dural puncture headache in spinal saddle block seems to be associated with the time given for fixation of the local anaesthetic. Under the assumption of an elevated cerebro-spinal-fluid pressure in the lumbar spine in the sitting position we hypothesised that (a) using a 27G-Pencil-Point® spinal needle instead of a 27G-Quincke-type® spinal needle AND (b) leaving the patient in the upright position for fixation of the local anaesthetic for 10 instead of 30 minutes would reduce the incidence of post-dural-puncture headache.

Ethics approval

Medical Ethics Committee II, Faculty of Medicine, Ruprecht Karl University of Heidelberg (Medizinische Ethikkommission II: Medizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg), approved on 27/09/2008.

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post-dural puncture headache

Intervention

Patients are randomised 1:1:1:1 to:

A: 27-gauge Quincke® needle, being left in the upright postion for 10 minutes
B: 27-gauge Quincke® needle, being left in the upright postion for 30 minutes
C: 27-gauge Pencil-Point® needle, being left in the upright postion for 10 minutes
D: 27-gauge Pencil-Point® needle, being left in the upright postion for 30 minutes

Patients receive a questionnaire and phone call one week later to obtain information about satisfaction and occurring complications. The time for the performance of the spinal anaesthesia and problems with the handling of the spinal needle are recorded by the anaesthesiologist.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of post-dural puncture headache and other complications, measured one week after anaesthesia.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2008

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male/female) with minor perianal surgery
2. Age 18-80 years
3. American Society of Anesthesiologists (ASA) physical status 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

01/09/2008

Recruitment end date

01/08/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsmedizin Mannheim
Mannheim
69167
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

University/education

Funder name

University of Heidelberg (Germany) - main funder

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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