Ultrasound guided spermatic cord block for scrotal surgery

ISRCTN	ISRCTN44647819
DOI	https://doi.org/10.1186/ISRCTN44647819
Secondary identifying numbers	N/A

Submission date: 10/05/2009
Registration date: 26/06/2009
Last edited: 23/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marius Wipfli
Scientific

University Hospital Berne
Bern
3010
Switzerland

Email	marius.wipfli@insel.ch

Study information

Study design	Non-randomised, non-controlled feasibility pilot study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Ultrasound guided spermatic cord block for scrotal surgery: a feasibility pilot study
Study objectives	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(s)	Local ethics committee (Kantonale Ethikkommission KEK) approved on the 10th November 2008 (ref: 167/08)
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2009
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key inclusion criteria	Electively planned patients (male or female aged at least 16 years - no upper age limit), for subcapsular orchiectomy or vaso-vasostomy.
Key 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)
Date of first enrolment	01/01/2009
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Berne

Bern
3010
Switzerland

Sponsor information

University of Bern (Switzerland)
University/education

Department of Anaesthesia and Pain Therapy
Inselspital Bern
Bern
3010
Switzerland

Email	marius.wipfli@insel.ch
Website	http://www.unibe.ch/eng/
"ROR"	https://ror.org/02k7v4d05

Funders

Funder type

University/education

University of Berne (Switzerland) - Scientific fund of the Department of Anaesthesia and Pain Therapy

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No