25- versus 29-gauge Quincke spinal needles

ISRCTN	ISRCTN11431649
DOI	https://doi.org/10.1186/ISRCTN11431649
Secondary identifying numbers	anaesMA2007-03

Submission date: 12/12/2007
Registration date: 20/03/2008
Last edited: 20/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Grietje Beck
Scientific

University Clinic Mannheim
Department of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Email	grietje.beck@anaes.ma.uni-heidelberg.de

Study information

Study design	Single centre, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2008
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	600
Key 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
Key exclusion criteria	1. Contraindications for spinal anaesthesia 2. Allergy against local anaesthetics
Date of first enrolment	01/02/2008
Date of final enrolment	31/01/2009

Locations

Countries of recruitment

Germany

Study participating centre

University Clinic Mannheim

Mannheim
68167
Germany

Sponsor information

B. Braun Melsungen AG (Germany)
Industry

Carl-Braun-Strasse 1
Melsungen
34212
Germany

Email	info@bbraun.com
Website	http://www.bbraun.com/
"ROR"	https://ror.org/04nxj7050

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan