Contact information
Type
Scientific
Primary contact
Dr Marius Wipfli
ORCID ID
Contact details
University Hospital Berne
Bern
3010
Switzerland
marius.wipfli@insel.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Ultrasound guided spermatic cord block for scrotal surgery: a feasibility pilot study
Acronym
Study hypothesis
Blindly performed spermatic cord blockade are known to be difficult, painful and has potential risk (intravasal injection of local anaesthesia, perforation of vessels and perforation of the deferent duct). The aim of this study is to test the feasibility of ultrasound guided spermatic cord blockade.
Ethics approval
Local ethics committee (Kantonale Ethikkommission KEK) approved on the 10th November 2008 (ref: 167/08)
Study design
Non-randomised, non-controlled feasibility pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Regional anaesthesia
Intervention
After antiseptic cleaning of the external genitalia, the spermatic cord is grasped gently between the left thumb and index finger. Using a 2 cm pedriatic ultrasound probe the spermatic cord is identified by searching the testicular artery and the deferent duct. Using a 22 G Microlance needle the local anaesthesia (10 ml) is slowly injected around the ductus deferens avoiding vessel perforation.
Patients will then receive either a subcapsular orchiectomy or a vaso-vasostomy.
As of 17/06/2010 the above anticipated end date of this trial has been amended to the actual end date. The initial anticipated end date at the time of registration was 31/12/2009.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Success rate of the blockade defined as surgery without any substitution (analgesics, conversion to general anaesthesia).
Secondary outcome measures
1. Visual Analogue Scale (VAS) (0 - 10) during blockade and every 30 minutes after beginning of surgery
2. Volume of local anaesthesia for blockade
3. Duration of blockade: defined as point of time of the first demand of analgesics after surgery
4. Patient satisfaction (scale 0 - 5) in general 1 week after surgery
Overall trial start date
01/01/2009
Overall trial end date
01/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Electively planned patients (male or female aged at least 16 years - no upper age limit), for subcapsular orchiectomy or vaso-vasostomy.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Refusal of regional anaesthesia
2. Patients with anticoagulation
3. Anamnesis of haemorrhagic diathesis
4. Adipositas (Body Mass Index [BMI] greater than 40)
Recruitment start date
01/01/2009
Recruitment end date
01/03/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Berne
Bern
3010
Switzerland
Sponsor information
Organisation
University of Bern (Switzerland)
Sponsor details
Department of Anaesthesia and Pain Therapy
Inselspital Bern
Bern
3010
Switzerland
marius.wipfli@insel.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Berne (Switzerland) - Scientific fund of the Department of Anaesthesia and Pain Therapy
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21068049
Publication citations
-
Results
Wipfli M, Birkhäuser F, Luyet C, Greif R, Thalmann G, Eichenberger U, Ultrasound-guided spermatic cord block for scrotal surgery., Br J Anaesth, 2011, 106, 2, 255-259, doi: 10.1093/bja/aeq301.