Condition category
Signs and Symptoms
Date applied
12/12/2007
Date assigned
20/03/2008
Last edited
20/03/2008
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

Prof Grietje Beck

ORCID ID

Contact details

University Clinic Mannheim
Department of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
grietje.beck@anaes.ma.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

anaesMA2007-03

Study information

Scientific title

Comparison of 25- versus 29-gauge Quincke spinal needles for minor anorectal surgery as well as abdominal caesarean section in respect of patient satisfaction and handling

Acronym

Study hypothesis

It is considered, that the incidence of post-puncture dural headache is correlated with the size of the spinal needle. For reason of patients' satisfaction and to minimize complications, a 29-gauge spinal needle is suitable for this purpose, especially in pregnant patients and patients undergoing ambulatory surgery. Though, the handling of this very thin spinal needle is described as difficult and therefore denied by several anaesthesiologists.

The aim of this study is to evaluate the patients' satisfaction, the incidence of post-puncture dural headache and the handling conditions for the anaesthesiologist.

Hypothesis:
The performance of a spinal anaesthesia with 29-gauge compared to a 25-gauge Quincke needles has a lower incidence of complications in patients undergoing minor anorectal surgery and abdominal caesarean section.

Ethics approval

Ethics approval received from the local medical ethics committee (Medizinische Ethik-Kommission II: Medizinische Fakultat Mannheim der Ruprecht-Karls-Universitat Heidelberg) on the 19th September 2007 (ref: 2007-236N-MA).

Study design

Single centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post-puncture dural headache

Intervention

The patients are 1:1 randomised to either a 25-gauge or a 29-gauge spinal needle. Patients receive a questionnaire 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 Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Time for the performance of spinal anaesthesia and occurring complications, measured one week after anaesthesia.

Overall trial start date

01/02/2008

Overall trial end date

31/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male/female) with minor anorectal surgery, or
2. Patients (female) for abdominal caesarean section
3. Age 18 - 80 years
4. American Society of Anaesthesiology (ASA) grade I - III
5. No contraindications for spinal anaesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

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

Recruitment start date

01/02/2008

Recruitment end date

31/01/2009

Locations

Countries of recruitment

Germany

Trial participating centre

University Clinic Mannheim
Mannheim
68167
Germany

Sponsor information

Organisation

B. Braun Melsungen AG (Germany)

Sponsor details

Carl-Braun-Strasse 1
Melsungen
34212
Germany
info@bbraun.com

Sponsor type

Industry

Website

http://www.bbraun.com/

Funders

Funder type

Industry

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