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

K

Kaplan Medical Center

Status

Unknown

Conditions

Pain

Treatments

Other: Local hypothermia
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT02943772
0092-16-KMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male patients 18-99 years
  • Acute epididymitis or acute orchiepididymitis

Exclusion criteria

  • Patient unable to informed consent
  • Suspicion of testicular malignancy

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Local hypothermia
Experimental group
Description:
Local application of a brick cooled to -20(celsius)
Treatment:
Other: Local hypothermia
Control
Sham Comparator group
Description:
Local application of a brick in room temperature
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

Yuval Avda, MD; Igal Shpunt, MD

Data sourced from clinicaltrials.gov

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