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ISRCTN
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ISRCTN11431649
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ClinicalTrials.gov identifier
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Public title
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25- versus 29-gauge Quincke spinal needles
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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anaesMA2007-03
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Study hypothesis
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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.
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Ethics approval
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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).
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Study design
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Single centre, randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Post-puncture dural headache
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Contraindications for spinal anaesthesia
2. Allergy against local anaesthetics
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Anticipated start date
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01/02/2008
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Anticipated end date
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31/01/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600
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Interventions
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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.
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Primary outcome measure(s)
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Incidence of post-dural puncture headache and other complications, measured one week after anaesthesia.
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Secondary outcome measure(s)
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Time for the performance of spinal anaesthesia and occurring complications, measured one week after anaesthesia.
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Sources of funding
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B. Braun Melsungen AG (Germany) - provided the spinal needles
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Trial website
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Publications
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Contact name
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Prof
Grietje
Beck
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Address
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University Clinic Mannheim
Department of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
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City/town
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Mannheim
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Zip/Postcode
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68167
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Country
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Germany
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Email
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grietje.beck@anaes.ma.uni-heidelberg.de
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Sponsor
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B. Braun Melsungen AG (Germany)
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Address
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Carl-Braun-Strasse 1
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City/town
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Melsungen
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Zip/Postcode
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34212
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Country
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Germany
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Email
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info@bbraun.com
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Sponsor website:
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http://www.bbraun.com/
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Date applied
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12/12/2007
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Last edited
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20/03/2008
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Date ISRCTN assigned
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20/03/2008
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