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Cryotherapy for Postoperative Pain (ICE Trial)

N/A
Waitlist Available
Led By Paul Karanicolas, MD PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Scheduled for an elective surgery requiring a thoracic, abdominal or groin incision
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

ICE Trial Summary

This trial is testing whether using ice packs on surgical incisions can help with pain management.

Who is the study for?
This trial is for adults over 18 who are staying in the hospital at least one night after elective surgery with a thoracic, abdominal, or groin incision. It's not for those expected to need overnight intubation post-surgery or individuals with Raynaud's phenomenon.Check my eligibility
What is being tested?
The study tests if applying ice packs every 4 hours on surgical incisions helps improve recovery quality compared to standard care alone. Participants will be randomly chosen to either use cryotherapy along with regular treatment or receive only the usual care.See study design
What are the potential side effects?
Cryotherapy may cause local discomfort, numbness, and potential skin irritation at the site of application. However, it is generally considered safe and side effects are typically mild.

ICE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for surgery that involves cutting into my chest, belly, or groin.
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I will stay in the hospital for at least one night after surgery.

ICE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of accrual (one year)
Estimation of Quality of Recovery (QoR) in patients treated with cryotherapy vs. no cryotherapy
Proportion of complete data collection for patient-reported outcome surveys, across all sites
+2 more

ICE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CryotherapyExperimental Treatment1 Intervention
Cold therapy
Group II: No cryotherapyActive Control1 Intervention
Standard practices for pain management

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,481 Total Patients Enrolled
1 Trials studying Postoperative Pain
140 Patients Enrolled for Postoperative Pain
Paul Karanicolas, MD PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
5 Previous Clinical Trials
4,099 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Effect of Intermittent Cryotherapy Exposure on Patients' Quality of Recovery After Surgery
Dr. Paul Karanicolas 2021. "The Effect of Intermittent Cryotherapy Exposure on Patients' Quality of Recovery After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04564963.
~56 spots leftby Apr 2025
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