Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake?

Study Overview
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Brief Summary
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The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.

Detailed Description
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Epididymitis or orchiepididymitis is an acute disease causing pain and discomfort. our hypothesis is that local cooling of the affected testis or epididymis may relieve the pain and reduce the analgetics consumption In order to examine this hypothesis we will recruit adult patients with epididymitis or orchiepididymitis and will randomize these patients to two arms. One arm will receive every 8 hours a brick cooled for at least 2 hours in -20(celsius) for local use on the affected hemiscrotum, while the second arm will receive a brick in room temperature. Pain level will be estimated one hour following the application of the brick using visual analogue pain score. Patient will receive analgetics according to a predefined escalating protocol. Pain level and analgetics consumption will be compared between the two arms.

Official Title
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Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level

Conditions
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Pain

Intervention / Treatment
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* Other: Local hypothermia
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients 18-99 years Acute epididymitis or acute orchiepididymitis Exclusion Criteria: Patient unable to informed consent Suspicion of testicular malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local hypothermia<br>Local application of a brick cooled to -20(celsius) | Other: Local hypothermia<br>* Cooled brick<br>|
| Sham Comparator: Control<br>Local application of a brick in room temperature | Other: Control<br>* Control brick<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain level | intervention and measurement will be examined three times a day following brick/cooled brick | pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption in grams of protocol analgetics | each protocol Analgetic will be summarized individually in grams | analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks |