Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001094066
Ethics application status
Approved
Date submitted
14/12/2010
Date registered
14/12/2010
Date last updated
14/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the feasiblity of the use of ultrasound-guided spermatic cord block in patients undergoing vasectomy reversal in a prospective interventional study with a historical comparison group
Scientific title
Assessing the feasibility of ultrasound-guided spermatic cord block in patients undergoing vasectomy reversal in a prospective interventional study with a historical comparison group.
Secondary ID [1] 253291 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasectomy reversal 258817 0
Anesthesia 258818 0
Condition category
Condition code
Surgery 258964 258964 0 0
Surgical techniques
Anaesthesiology 258966 258966 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients scheduled for vasectomy reversal are prospectively included into the study. Vasectomy reversal is done in regional anesthesia with an ultrasound-guided spermatic cord block instead of general or neuraxial anesthesia. The ultrasound-guidance is done under sterile conditions 15 minutes before surgery on each side at the inguinoscrotal level by injection of 5ml short- and 5ml long-acting local anesthesia. Before, during and after the operation pain-level by visual-analogue-scale (VAS) and general anesthesiological values are monitored on a regular base. Postoperatively, monitoring of first request of an analgetic treatment, first alimentation, first mobilization and discharge is noted until discharge of the patient, which usually takes place within 24 hours. Analysis of complications until 7 days postoperatively. End of monitoring 7 days postoperatively.
Intervention code [1] 257742 0
Treatment: Surgery
Intervention code [2] 257744 0
Treatment: Other
Comparator / control treatment
A consecutive historical comparison group of the same number of patients having had vasectomy reversal in general or neuraxial anesthesia is analyzed and compared in terms of postoperative analgetic treatment, first alimentation and mobilization, discharge and complications.
Control group
Historical

Outcomes
Primary outcome [1] 259820 0
Success rate of the spermatic cord block, which was defined as surgery with no or light pains VAS <= 3 (0 no pain up to 10 worst imaginable pain) without any substitution of opioids, additional local anesthetics, or conversion to general or neuraxial anesthesia.
Timepoint [1] 259820 0
Pains and eventual substitution of opioids, additional local anesthetics or conversion to general or neuraxial anesthesia are assessed before the injection of the block (15 min before surgery) for baseline, during the injection of the block (15 min before surgery), at the beginning of surgery, during surgery every 30 min, and at the end of surgery.
Secondary outcome [1] 268626 0
Intraoperative microsurgical conditions evaluated by the surgeon according to a scale-system.
Timepoint [1] 268626 0
During the microsurgical part of surgery, which takes place 15 min after start of surgery. Reevaluation until the end of surgery, if conditions change.
Secondary outcome [2] 268627 0
Pains assessed by the VAS.
Timepoint [2] 268627 0
5 minutes before block (baseline), during the injection of the block, 15 minutes after the begin of surgery, then every 30 minutes until the end of surgery.
Secondary outcome [3] 268628 0
Number of inadvertent vascular punctures during ultrasound-guided spermatic cord block. This outcome is assessed visually by ultrasound during the ultrasound-guided spermatic cord block. Assessed are intracordal bleedings and hematomas.
Timepoint [3] 268628 0
During injection of the block.
Secondary outcome [4] 268629 0
Number of intraoperative spermatic cord haematoma, assessed by visual control of the spermatic cord at the level of injection by the surgeon.
Timepoint [4] 268629 0
Before the end of surgery on each side.
Secondary outcome [5] 268630 0
Number of patients reporting postoperative nausea and vomiting (PONV) and urinary retentions. PONV is assessed using reports of the postoperative care unit. Urinary retention is assessed using questioning of patient by the surgeon and ultrasound of residual urine, if postoperative bladder voiding has not taken place until 6 hours postoperatively and a feeling of a full bladder exists.
Timepoint [5] 268630 0
During the first 24 hours after surgery.
Secondary outcome [6] 268631 0
Time between end of surgery and first mobilization (assessed by postoperative care unit, when patient calls for immediately postoperatively offered first mobilization), first alimentation (assessed by postoperative care unit, when patient calls for immediately postoperatively offered first alimentation), and demission (time noted in files).
Timepoint [6] 268631 0
Assessed regularely (on call) as soon as requested until discharge from hospital.
Secondary outcome [7] 268632 0
Duration of the block, which was defined as time between injection of the block and first request of postoperative analgesic by the patient.
Timepoint [7] 268632 0
Assessed regularely (on call) as soon as requested because of discomfort in the operated area until discharge from hospital.
Secondary outcome [8] 268633 0
Overall patient satisfaction with the spermatic cord block as the method of anesthesia.
Timepoint [8] 268633 0
Assessed by telephone interview 7 days after surgery, pointed out as follows: 1 = very satisfactory, 2 = satisfactory, 3 = indifferent, 4 = unsatisfactory, 5 = very unsatisfactory.

Eligibility
Key inclusion criteria
Males after vasectomy scheduled for vasectomy reversal surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of regional anesthesia.
Adiposity with a body-mass-index over 40.
Known bleeding disorders.
Blood coagulation abnormalities as International Normalized Ratio (INR) >1.5 or platelet count <100`000/µl

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Inclusion of a consecutive series into a prospective trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Historical comparison group.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 3087 0
Switzerland
State/province [1] 3087 0

Funding & Sponsors
Funding source category [1] 258207 0
Hospital
Name [1] 258207 0
Department of Urology, Inselspital Bern
Country [1] 258207 0
Switzerland
Funding source category [2] 258208 0
Hospital
Name [2] 258208 0
Department of Anaesthesia and Pain Therapy, Inselspital Bern
Country [2] 258208 0
Switzerland
Primary sponsor type
Hospital
Name
Department of Urology, Inselspital Bern
Address
Anna Seiler-Haus
Inselspital
CH-3010 Bern
Country
Switzerland
Secondary sponsor category [1] 257379 0
None
Name [1] 257379 0
Address [1] 257379 0
Country [1] 257379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260191 0
Kantonale Ethikkommission Bern (KEK)
Ethics committee address [1] 260191 0
Ethics committee country [1] 260191 0
Switzerland
Date submitted for ethics approval [1] 260191 0
Approval date [1] 260191 0
10/11/2008
Ethics approval number [1] 260191 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32013 0
Address 32013 0
Country 32013 0
Phone 32013 0
Fax 32013 0
Email 32013 0
Contact person for public queries
Name 15260 0
Frederic Birkhaeuser
Address 15260 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 15260 0
Switzerland
Phone 15260 0
+41 31 632 36 41
Fax 15260 0
Email 15260 0
[email protected]
Contact person for scientific queries
Name 6188 0
Frederic Birkhaeuser
Address 6188 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 6188 0
Switzerland
Phone 6188 0
+41 31 632 36 41
Fax 6188 0
Email 6188 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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