Selection of candidates for surgery by means of three separate blind administered high scrotal injections in men with chronic scrotal pain and objective evaluation of these patients
| ISRCTN | ISRCTN36325305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36325305 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/08/2013
- Registration date
- 23/10/2013
- Last edited
- 04/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Heidelberglaan 100
Utrecht
3584CX
Netherlands
Study information
| Study design | Prospective double-blind observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective double-blind preoperative pain clinic screening before microsurgical denervation of the spermatic cord in patients with chronic orchialgia |
| Study objectives | 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(s) | None, the injections and surgery are standard of care. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/1999 |
| Completion date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 300 |
| Total final enrolment | 180 |
| Key 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 |
| Key exclusion criteria | 1. Underlying treatable causes 2. Psychiatric disorders that could be the cause of the pain |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3584CX
Netherlands
Sponsor information
University/education
c/o Mr Tycho M.T.W. Lock
Department of Urology
Heidelberglaan 100
Utrecht
3584CX
Netherlands
"ROR" |
https://ror.org/0575yy874 |
|---|
Funders
Funder type
University/education
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 | 01/09/2014 | 04/05/2020 | Yes | No |
Editorial Notes
04/05/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The recruitment end date has been changed from 01/01/2050 to 01/01/2013.
4. The overall trial end date has been changed from 01/01/2050 to 01/01/2014.
