Clinical trial NCT04564963: The Effect of Intermittent Cryotherapy Exposure on Patients' Quality of Recovery After Surgery
Official title: The Effect of Intermittent Cryotherapy Exposure (ICE) on Patients' Quality of Recovery After Surgery: A Vanguard Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Cryotherapy
Cold therapy
Pain management
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, pragmatic, open label, two-arm parallel-group Vanguard feasibility randomized controlled trial
Primary purpose: TREATMENT

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.

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:

1. To assess the investigators' ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year.
2. 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.
3. 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.
4. To examine the investigators' ability to carry out data linkages using the IMPACTS Program design platform over the course of one year.
5. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Assessment of accrual (one year)
timeFrame: 1 year
measure: Proportion of participants who received the allocated intervention, across all sites
timeFrame: 1 year
measure: Proportion of complete data collection for patient-reported outcome surveys, across all sites
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Estimation of Quality of Recovery (QoR) in patients treated with cryotherapy vs. no cryotherapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Paul Karanicolas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: