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The Effect of Intermittent Cryotherapy Exposure on Patients' Quality of Recovery After Surgery

NCT04564963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-01-12

No results posted yet for this study

Summary

"Cryotherapy", or cold therapy, can include the use of gel packs, ice bags, ice baths, whole body chambers, and cold aerosol sprays. It is a popular non-drug treatment that can be used after a surgical operation, along with medication such as narcotics and anti-inflammatories for pain management. The application of ice packs on areas of injury has been used for many decades, as they can decrease both inflammation and pain. Other possible benefits include reduced blood flow, swelling, and tissue damage as well as muscle spasms. While there is some evidence to suggest that the use of ice packs is beneficial, this has not yet been implemented into practice, nor do any guidelines recommend the use of ice packs for pain management in surgical patients. In this trial, adult patients undergoing scheduled thoracoabdominal or groin surgery will be randomly assigned to apply ice packs over the largest closed surgical incision every 4 hours, at minimum, for 72 hours (while the patient is awake), along with standard of care, or to receive standard of care only. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest are quality of patient recovery, pain, length of hospital stay and medication use.

Conditions

  • Postoperative Pain

Interventions

OTHER

Cryotherapy

Application of cryotherapy (e.g. ice in resealable zipper storage bags, gel packs, ice packs) over largest closed incision in the post-operative period every 4 hours, at minimum, for up to 72 hours (while participant is awake and admitted to hospital). The cryotherapy should not be placed in direct contact with skin.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Paul Karanicolas, MD PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2022-07-25
Completion
2022-08-21

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04564963 on ClinicalTrials.gov