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

NCT04564963 | Completed

• 1 other identifier: CTO Project ID 2021
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cryotherapy; Cold therapy; Pain management

Outcome Measures

Primary Outcomes (5)

• Assessment of accrual (one year)

  Average number of patients enrolled per month across the 3 sites for the trial: feasible if 10 or more

  1 year

• Proportion of participants who received the allocated intervention, across all sites

  Feasible if \>90% of patients receive correct intervention

  1 year

• Proportion of complete data collection for patient-reported outcome surveys, across all sites

  Feasible if \>80% of data is collected

  1 year

• Proportion of successful data linkage of patient-reported outcome data with Institute of Clinical Evaluative Sciences and National Surgical Quality Improvement Program dataset(s), across all sites

  Feasible if linkage is possible in \>90% of patients

  1 year

• Estimation of Quality of Recovery (QoR) in patients treated with cryotherapy vs. no cryotherapy

  Quality of patient recovery will be measured using the QoR-15 score at post-operative day 1 (POD1). The QoR-15 score ranges from 0-150 (the higher the score, the better the recovery).

  1 year

Study Arms (2)

Cryotherapy

EXPERIMENTAL

Cold therapy

Other: Cryotherapy

No cryotherapy

NO INTERVENTION

Standard practices for pain management

Interventions

Cryotherapy OTHER

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.

Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Scheduled for an elective surgery requiring a thoracic, abdominal or groin incision
• Scheduled to remain in hospital for at least one night, post-operatively

You may not qualify if:

• Anticipated to require intubation overnight post-operatively
• Raynaud's phenomenon

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (3)

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Paul Karanicolas, MD PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist and Associate Professor

Model Details: Multi-centre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 25, 2020
• Study Start: October 5, 2021
• Primary Completion: July 25, 2022
• Study Completion: August 21, 2022
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)