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
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