Postoperative PainICENCT04564963
The Effect of Intermittent Cryotherapy Exposure on Patients' Quality of Recovery After Surgery
A study testing Cryotherapy in people with Postoperative Pain, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 3 sitesCanada
- Study dates
- 5 Oct 2021to 21 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anticipated to require intubation overnight post-operatively
- Raynaud's phenomenon
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
North York General Hospital
North York, Ontario, M2K 1E1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: The Effect of Intermittent Cryotherapy Exposure (ICE) on Patients' Quality of Recovery After Surgery: A Vanguard Randomized Control Trial
"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.
Read the detailed description
Background/rationale: To date, there is some evidence to suggest a benefit of cryotherapy application over closed post-operative incisions, however, this has not yet been implemented into practice. Furthermore, there are no clinical practice guidelines that recommend the application of cryotherapy for adjuvant pain management. Relevant randomized controlled trials (RCTs) in abdominal surgery demonstrate a possible advantage of cryotherapy application, when compared to no cryotherapy application. However, those RCTs were small and were restricted to gynecology procedures or emergent procedures. Therefore, the investigators aim to address this knowledge gap by assessing the benefit of applying cryotherapy post-operatively (along with standard of care approaches), compared to no cryotherapy, (i.e., standard of care, only) over closed incisions, across broad surgical specialties and procedures, to improve the quality of patient recovery in adult patients.
Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives:
- To assess the investigators' ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year.
- To assess the investigators' ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program design platform, over the course of one year.
- To assess the investigators' ability to collect complete data directly from participants (patients and clinicians) on: narcotics use and surgical site infections over the course of one year.
- To examine the investigators' ability to carry out data linkages using the IMPACTS Program design platform over the course of one year.
- To estimate the change in quality of recovery to inform the sample size calculation for the definitive trial.
Study design: This is a multicentre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial. Patients will be randomized to cryotherapy application or no cryotherapy application. If feasibility is demonstrated during the pilot trial, the investigators will plan to conduct a definitive trial. If there are only minimal changes to the protocol, the investigators will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).
- Conditions
- Postoperative Pain
- Being tested
- Cryotherapy
- Keywords
- Cryotherapy, Cold therapy, Pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Cold therapy Receives: Other: Cryotherapy |
| No cryotherapy | No intervention | Standard practices for pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of accrual (one year)
Average number of patients enrolled per month across the 3 sites for the trial: feasible if 10 or more
Measured: 1 year
Proportion of participants who received the allocated intervention, across all sites
Feasible if >90% of patients receive correct intervention
Measured: 1 year
Proportion of complete data collection for patient-reported outcome surveys, across all sites
Feasible if >80% of data is collected
Measured: 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
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start5 Oct 2021
- Primary completion25 Jul 2022
- Study completion21 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Karanicolas, Sunnybrook Health Sciences Centre
- Investigators
- Paul Karanicolas, MD PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564963
- Sponsor's protocol ID
- CTO Project ID 2021
- Acronym
- ICE
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Cryotherapy Exposure (ICE) on Patients' Quality of Recovery After Surgery: A Vanguard Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04564963
- Acronym / sponsor ID
- ICE / CTO Project ID 2021
- Conditions
- Postoperative Pain
- Keywords
- Cryotherapy, Cold therapy, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 21 Aug 2022 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Detailed description
Background/rationale: To date, there is some evidence to suggest a benefit of cryotherapy application over closed post-operative incisions, however, this has not yet been implemented into practice. Furthermore, there are no clinical practice guidelines that recommend the application of cryotherapy for adjuvant pain management. Relevant randomized controlled trials (RCTs) in abdominal surgery demonstrate a possible advantage of cryotherapy application, when compared to no cryotherapy application. However, those RCTs were small and were restricted to gynecology procedures or emergent procedures. Therefore, the investigators aim to address this knowledge gap by assessing the benefit of applying cryotherapy post-operatively (along with standard of care approaches), compared to no cryotherapy, (i.e., standard of care, only) over closed incisions, across broad surgical specialties and procedures, to improve the quality of patient recovery in adult patients.
Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives:
- To assess the investigators' ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year.
- To assess the investigators' ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program design platform, over the course of one year.
- To assess the investigators' ability to collect complete data directly from participants (patients and clinicians) on: narcotics use and surgical site infections over the course of one year.
- To examine the investigators' ability to carry out data linkages using the IMPACTS Program design platform over the course of one year.
- To estimate the change in quality of recovery to inform the sample size calculation for the definitive trial.
Study design: This is a multicentre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial. Patients will be randomized to cryotherapy application or no cryotherapy application. If feasibility is demonstrated during the pilot trial, the investigators will plan to conduct a definitive trial. If there are only minimal changes to the protocol, the investigators will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-centre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: CryotherapyCold therapy |
| No cryotherapy | No intervention | –Standard practices for pain management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Anticipated to require intubation overnight post-operatively
- Raynaud's phenomenon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyApplication 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. | Other | Cryotherapy |
Primary outcome
Assessment of accrual (one year)
Time frame: 1 year
Average number of patients enrolled per month across the 3 sites for the trial: feasible if 10 or more
Proportion of participants who received the allocated intervention, across all sites
Time frame: 1 year
Feasible if >90% of patients receive correct intervention
Proportion of complete data collection for patient-reported outcome surveys, across all sites
Time frame: 1 year
Feasible if >80% of data is collected
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
Time frame: 1 year
Feasible if linkage is possible in >90% of patients
Estimation of Quality of Recovery (QoR) in patients treated with cryotherapy vs. no cryotherapy
Time frame: 1 year
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Karanicolas, MD PhD principal investigator
Sunnybrook Health Sciences Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Postoperative Pain, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of accrual (one year) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.