Ultrasound guided spermatic cord block for scrotal surgery
| ISRCTN | ISRCTN44647819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44647819 |
| Protocol serial number | N/A |
| Sponsor | University of Bern (Switzerland) |
| Funder | University of Berne (Switzerland) - Scientific fund of the Department of Anaesthesia and Pain Therapy |
- 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
Scientific
University Hospital Berne
Bern
3010
Switzerland
| marius.wipfli@insel.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, non-controlled feasibility pilot study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Success rate of the blockade defined as surgery without any substitution (analgesics, conversion to general anaesthesia). |
| Key secondary outcome measure(s) |
1. Visual Analogue Scale (VAS) (0 - 10) during blockade and every 30 minutes after beginning of surgery |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
3010
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
