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
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