Condition category
Surgery
Date applied
10/05/2009
Date assigned
26/06/2009
Last edited
23/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unibe.ch/eng/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21068049

Publication citations

  1. 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.

Additional files

Editorial Notes