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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Local hypothermia; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Igal Shpunt, MD; Phone Number: +972-8-944-1642; Email: igal2k@gmail.com
• Study Contact Backup: Name: Yuval Avda, MD; Phone Number: +972-8-944-1516; Email: yuvalab@clalit.org.il

Study Locations

• Israel
  • Rehovot, Israel
    • Recruiting
    • Kaplan Medical Center
    • Contact: igal shpunt, MD; Phone Number: 972545857588; Email: igal2k@gmail.com
    • Sub-Investigator: Uri lindner, MD
    • Principal Investigator: Dan Leibovici, MD
    • Sub-Investigator: yuval avda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient unable to informed consent
• Suspicion of testicular malignancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaplan Medical Center
• Investigators: Principal Investigator: Dan Leibovici, MD, Kapaln medical center

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): November 7, 2019
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 22, 2016
• First Posted (Estimate): October 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Epididymitis
• Other Study ID Numbers: 0092-16-KMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO