Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- change in pain level
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients 18-99 years
- •Acute epididymitis or acute orchiepididymitis
Exclusion Criteria
- •Patient unable to informed consent
- •Suspicion of testicular malignancy
Arms & Interventions
Local hypothermia
Local application of a brick cooled to -20(celsius)
Intervention: Local hypothermia (Other)
Control
Local application of a brick in room temperature
Intervention: Control (Other)
Outcomes
Primary Outcomes
change in pain level
Time Frame: 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
intervention and measurement will be examined three times a day following brick/cooled brick
Secondary Outcomes
- Total consumption in grams of protocol analgetics(analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks)
Investigators
Dan Leibovici
professor
Kaplan Medical Center