Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000857606
Ethics application status
Approved
Date submitted
26/07/2023
Date registered
9/08/2023
Date last updated
9/08/2023
Date data sharing statement initially provided
9/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-Operative Ice BLock Accelerates Recovery (POLAR) project: a three-arm randomised controlled study.
Scientific title
The effect of post-operative consumption of a lemonade ice block on post-operative nausea and vomiting and related outcomes compared to unflavoured ice chips and standard care (no ice block or ice chips) in adults who have undergone surgery requiring general anaesthesia.
Secondary ID [1] 307792 0
None
Universal Trial Number (UTN)
Trial acronym
The POLAR Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative nausea and vomiting 327375 0
Condition category
Condition code
Anaesthesiology 324497 324497 0 0
Other anaesthesiology
Surgery 327770 327770 0 0
Other surgery
Public Health 327771 327771 0 0
Health service research
Oral and Gastrointestinal 327772 327772 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to Group 2 will receive standard care in addition to Intervention A (the consumption of ½ cup of unflavoured ice chips). Participants randomised to Group 3 will receive standard care in addition to Intervention B (the consumption of one lemonade flavoured ice block [ice confection]). Interventions A and B will be administered after the surgery completion once participants are in the recovery unit, have regained consciousness, and have been declared safe to eat the ice chips by nursing staff. Adherence to the intervention will be monitored by nursing staff who will report the amount of ice chips/ice block consumed.

As part of standard care, following the surgical procedure requiring general anaesthesia, participants are moved from the operating theatre to the post-anaesthesia recovery unit where they regain consciousness prior to being discharged home or to the hospital ward. If participants report feeling nauseous or are vomiting, they are offered antiemetic medications; therefore, there are no restrictions on prescribed antiemetic use in this project.
Intervention code [1] 324257 0
Treatment: Other
Comparator / control treatment
Participants randomised to Group 1 will receive standard care only. Following the surgical procedure requiring general anaesthesia, participants are moved from the operating theatre to the post-anaesthesia recovery unit where they regain consciousness prior to being discharged home or to the hospital ward. If participants report feeling nauseous or are vomiting, nurses offer oral antiemetic medications; therefore, there are no restrictions on antiemetics prescribed by treating surgeons or anaesthetists in this project (e.g., Ondansetron).
Control group
Active

Outcomes
Primary outcome [1] 332332 0
Early post-operative nausea and vomiting severity score measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [1] 332332 0
At T2 (post-surgery, at discharge from recovery unit).
Secondary outcome [1] 413044 0
Anticipatory post-operative nausea and vomiting severity score measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [1] 413044 0
At T0 (pre-surgery, within 24 hours of scheduled surgery).
Secondary outcome [2] 413045 0
Incidence of nausea as measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [2] 413045 0
At T0 (pre-surgery, within 24 hours of scheduled surgery), T2 (post-surgery, at discharge from recovery unit), and T3 (24 hours post-surgery).
Secondary outcome [3] 413046 0
Rescue antiemetic use as measured by hospital medical records.
Timepoint [3] 413046 0
At T2 (post-surgery, at discharge from recovery unit) and T3 (24 hours post-surgery).
Secondary outcome [4] 413047 0
Blood glucose level as measured using capillary blood via a finger prick.
Timepoint [4] 413047 0
At T0 (pre-surgery, within 24 hours of scheduled surgery) and T1 (post-surgery, on waking in recovery unit).
Secondary outcome [5] 413048 0
Quality of recovery as measured by Postoperative Quality of Recovery Short-Form (QoR-15).
Timepoint [5] 413048 0
At T3 (24 hours post-surgery).
Secondary outcome [6] 413049 0
Gastrointestinal recovery as measured by participant-reported time to tolerate an oral diet (i.e., soft food or light meal) via a study-specific questionnaire.
Timepoint [6] 413049 0
At T3 (24 hours post-surgery).
Secondary outcome [7] 413050 0
Post-anaesthesia recovery unit length of stay as measured by hospital medical records.
Timepoint [7] 413050 0
At T2 (post-surgery, at discharge from recovery unit).
Secondary outcome [8] 413051 0
Patient experience as measured by The Australian Hospital Patient Experience Question Set (AHPEQS).
Timepoint [8] 413051 0
T3 (24 hours post-surgery).
Secondary outcome [9] 424977 0
Incidence of vomiting as measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [9] 424977 0
At T0 (pre-surgery, within 24 hours of scheduled surgery), T2 (post-surgery, at discharge from recovery unit), and T3 (24 hours post-surgery).
Secondary outcome [10] 424978 0
Incidence of retching as measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [10] 424978 0
At T0 (pre-surgery, within 24 hours of scheduled surgery), T2 (post-surgery, at discharge from recovery unit), and T3 (24 hours post-surgery).
Secondary outcome [11] 424979 0
Nausea severity as measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [11] 424979 0
At T0 (pre-surgery, within 24 hours of scheduled surgery), T2 (post-surgery, at discharge from recovery unit), and T3 (24 hours post-surgery).
Secondary outcome [12] 424994 0
Number of vomiting episodes as measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [12] 424994 0
At T0 (pre-surgery, within 24 hours of scheduled surgery), T2 (post-surgery, at discharge from recovery unit), and T3 (24 hours post-surgery).
Secondary outcome [13] 424995 0
Number of retching episodes as measured by the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Timepoint [13] 424995 0
At T0 (pre-surgery, within 24 hours of scheduled surgery), T2 (post-surgery, at discharge from recovery unit), and T3 (24 hours post-surgery).

Eligibility
Key inclusion criteria
Participants who meet all of the following criteria will be considered for inclusion in the study:
• Aged 18 years and above
• Have capacity to give informed consent
• • Scheduled to undergo general (hernia, haemorrhoid, incision/drainage of rectal abscess), primary bariatric, or orthopaedic surgery requiring general anaesthesia
• Are willing to not use any self-prescribed nausea remedies in the 24 hours after the surgery (e.g., ginger supplements)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of any of the following criteria will constitute cause for exclusion of the participant:
• Scheduled for secondary bariatric surgeries or revisions
• Women who are pregnant
• Notification from treating surgeon that participant is not deemed to have capacity to consent or is not suitable for inclusion
• No access to email
• Those who do not provide consent at least 48 hours prior to their scheduled surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Data will be concealed until after baseline via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
2/01/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312062 0
University
Name [1] 312062 0
Queensland University of Technology
Country [1] 312062 0
Australia
Funding source category [2] 312069 0
Hospital
Name [2] 312069 0
St Vincent's Hospital - Northside
Country [2] 312069 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 313567 0
Hospital
Name [1] 313567 0
St Vincent's Hospital - Northside
Address [1] 313567 0
627 Rode Rd, Chermside QLD 4032
Country [1] 313567 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311472 0
St Vincent’s Health and Aged Care Human Research Ethics Committee
Ethics committee address [1] 311472 0
Ethics committee country [1] 311472 0
Australia
Date submitted for ethics approval [1] 311472 0
24/11/2022
Approval date [1] 311472 0
25/07/2023
Ethics approval number [1] 311472 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121214 0
Dr Megan Crichton
Address 121214 0
Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 121214 0
Australia
Phone 121214 0
+61731386322
Fax 121214 0
Email 121214 0
[email protected]
Contact person for public queries
Name 121215 0
Megan Crichton
Address 121215 0
Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 121215 0
Australia
Phone 121215 0
+61731386322
Fax 121215 0
Email 121215 0
[email protected]
Contact person for scientific queries
Name 121216 0
Megan Crichton
Address 121216 0
Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 121216 0
Australia
Phone 121216 0
+61731386322
Fax 121216 0
Email 121216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.