Condition category
Signs and Symptoms
Date applied
28/08/2013
Date assigned
23/10/2013
Last edited
23/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic scrotal pain can be treated by surgery as a last resort. The surgical procedure is called microsurgical denervation of the spermatic cord. We think that patients who are carefully selected for surgery have a better outcome than patients who receive surgery without any kind of screening. Screening (by means of a preoperative temporary injection with an anesthetic) is already considered 'best practice' so we can only compare our results with those in previous studies. The aim is to determine the pain reduction rate after injections and prior to surgery and to confirm that patients that are screened that way have better results.

Who can participate?
All men who fit the definition of chronic scrotal pain: intermittent or constant pain of varying degree in one or both testicles for a duration of at least 3 months which leads to significant reduction of daily activities with no underlying cause.

What does the study involve?
All men with chronic scrotal pain are invited to the pain clinic where they receive 3 injections (called inguinal temporary nerve blockades): a short-lasting anaesthetic, a long-lasting anaesthetic an a dummy injection (called a placebo) in a random order.
Patients who achieve more than 50% reduction in pain can have surgery.
If patients realise that they received the dummy injection and the pain reduction is at least 50%, a microsurgical denervation is offered to permanently cut the nerve fibers.
Patients who are not eligible for surgery are referred to the pain clinic to undergo spinal cord blockades or alternative treatment with drugs/psychotherapy.
The screening process is a test to determine if the patients are eligible for surgery, because all 3 injections are administered to one patient. The patient itself is his own 'controlÂ’. We are not trying to assess whether the order of the injections has an impact on the % of pain reduction.

Where is the study run from?
The University Medical Centre Utrecht, Netherlands.

When is the study starting and how long is it expected to run for?
It started in 1999 and is ongoing.

What are the possible benefits and risks of participating?
There are very few to no risks for participants. The injections are performed with a short-acting
anaesthetic (lidocain or bupivacain). In most hospitals, an injection with a local anaesthetic is a
standard procedure before performing surgery. The injections take place on three different days and takes about a 1/2 hour.

Who is funding the project?
Overall the Department of Urology, University Medical Center Utrecht (Universitair Medisch Centrum Utrecht) (Netherlands). Injections prior to surgery are part of standard care and there is no specific additional funding.

Who is the main contact?
MTWT Lock
m.t.w.t.lock@umcutrecht.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tycho Lock

ORCID ID

Contact details

Heidelberglaan 100
Utrecht
3584CX
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective double-blind preoperative pain clinic screening before microsurgical denervation of the spermatic cord in patients with chronic orchialgia

Acronym

Study hypothesis

What is the efficacy in terms of pain reduction after surgery (microsurgical denervation of the spermatic cord) after carefully screening patients by means of three blockades in a randomized order?

Ethics approval

None, the injections and surgery are standard of care.

Study design

Prospective double-blind observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic orchialgia

Intervention

All men included in the study suffer from orchialgia on the right or left or both sides.
Prior to possible surgery (inguinal approach for microsurgical denervation of the spermatic cord) all men undergo 3 injections in the high scrotal region to give a depot around the spermatic cord for temporary nerve blockade.
All patients will have 3 temporary nerve blockades on one side in a randomized order: bupivacain, lidocain and placebo in 3 separate sessions (mostly 1 week in between).
If a pain reduction above 50% happens during a reasonable period (bupivacain 4-12 hours,lidocain 2-6 hours, placebo no effect) they are candidates for surgery.
Only one side at a time is evaluated and operated on.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pain reduction after surgery
Outpatient clinic evaluation at 6 weeks and three months postoperatively and thereafter yearly by telephone interviewing (in case of complaints, patients are always seen immediately)

Secondary outcome measures

1. Patient satisfaction
2. Complications
3. Evaluation of blockades in randomized order

Overall trial start date

01/01/1999

Overall trial end date

01/01/2050

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with chronic orchialgia by definition: intermittent or constant pain of varying degree in one or both testicles for a duration of at least 3 months with leads to significant reduction of daily activities with no underlying cause

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

300

Participant exclusion criteria

1. Underlying treatable causes
2. Psychiatric disorders that could be the cause of the pain

Recruitment start date

01/01/1999

Recruitment end date

01/01/2050

Locations

Countries of recruitment

Netherlands

Trial participating centre

Heidelberglaan 100
Utrecht
3584CX
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (Universitair Medisch Centrum Utrecht) (Netherlands)

Sponsor details

c/o Mr Tycho M.T.W. Lock
Department of Urology
Heidelberglaan 100
Utrecht
3584CX
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Department of Urology, University Medical Center Utrecht (Universitair Medisch Centrum Utrecht) (Netherlands)

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

Publication citations

Additional files

Editorial Notes