Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001451897
Ethics application status
Approved
Date submitted
27/09/2021
Date registered
25/10/2021
Date last updated
1/10/2023
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Opioid PrEscRiptions and Usage After Surgery (OPERAS): a prospective multicentre observational cohort study of opioid use after common surgical procedures
Scientific title
Opioid PrEscRiptions and Usage After Surgery: an international, multi-centre prospective observational study of the prescription and usage of opioids after common surgical procedures
Secondary ID [1] 305423 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
OPERAS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Opioid prescription and usage after undergoing a surgery 323795 0
Condition category
Condition code
Anaesthesiology 321306 321306 0 0
Pain management
Surgery 321520 321520 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No interventions will be used. Opioiates prescribed and consumed will be determined based on oral morphine equivalents prescribed and consumed at discharge and 7-days.

A study aiming to quantify the amount of opiate medication prescribed at hospital discharge after surgery and identify the proportion of prescription medication consumed by patients at 7-days post-discharge. The study also aims to describe the variations in opioid prescriptions and consumptions by procedure and specialty, quantify the impact of quantity of analgesia on patient-reported satisfaction, identify risk factors for opioid consumption and over-prescription at 7-days, and to describe the use of ancillary analgesia after post-discharge after common procedure.

Participants that are eligible for inclusion will be approached while they are in hospital and informed consent will be sought. Patient data will be collected through the clinical record while patients are in hospital. At 7-days after patients have been discharged from hospital they will receive a phone-call (preceded by a text-message to introduce the researcher and purpose for the call). The phone call is anticipated to take 10 minutes or less and will ask abou the consumption of analgesia / pain medications in the past 7-day as well as questions about satisfaction regarding pain relief and quality of life questions (via the EQ-5D).

Intervention code [1] 321824 0
Not applicable
Comparator / control treatment
Comparisons will be made based on quantity of oral morphine equivalents prescribed and consumed, i.e., for each specialty, the quantity of oral morphine equivalents prescribed will be compared to the quantity of oral morphine equivalents consumed (based on patient-reported outcomes at the 7-day call). Therefore the prescribed and consumed quantities will be compared for each specialty.
Control group
Active

Outcomes
Primary outcome [1] 329088 0
Proportion and amount (morphine equivalent doses) of prescribed opiates - this will be determined by recording the opioids prescribed at discharge (based on discharge summaries, patient prescriptions and clinical records) and the same will be done by asking how many pills or mls of liquid opioids were consumed by patients. Doses from medications will be converted based on the ANZCA guidelines (ANZCA. PS01(PM) (Appendix). 2021.).
Timepoint [1] 329088 0
7-days post-discharge
Secondary outcome [1] 401399 0
Quality of life via EQ5D-5L
Timepoint [1] 401399 0
7-days post-discharge
Secondary outcome [2] 402026 0
Postoperative pain scale via the numeric rating scale
Timepoint [2] 402026 0
7-days post-discharge
Secondary outcome [3] 402027 0
Adequacy of pain relief prescribed via telephone questionnaire
Timepoint [3] 402027 0
7-days post-discharge
Secondary outcome [4] 402028 0
Requirement for further analgesia via telephone questionnaire
Timepoint [4] 402028 0
7-days post-discharge
Secondary outcome [5] 402029 0
Hospital readmissions for opiate-related side-effects or pain related to surgical pathology/procedure - collected via telephone questionnaire
Timepoint [5] 402029 0
7-days post-discharge

Eligibility
Key inclusion criteria
Adult patients (greater than or including 18 years of age)
Acute or elective surgery
Operated on within the pre-specified study periods
Discharged to home/community/ usual residence
Undergoing any of the following surgeries:
General Surgery
- Cholecystectomy
- Appendicectomy
- Inguinal hernia repair
- Colon resection with or without stoma
- Sleeve gastrectomy


Orthopaedic Surgery
- Total shoulder arthroplasty/reverse shoulder arthroplasty
- Rotator cuff repair/labral repair
- ACL repair
- Hip arthroplasty
- Knee arthroplasty


Gynaecology
- Hysterectomy
- Oophorectomy and/or Salpingectomy

Urology
- Prostatectomy
- Cystectomy
- Nephrectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric patients (below 18 years of age)
On the opiate replacement programme (on methadone, suboxone, buprenorphine)
Patients discharged to hospice or with palliative intent
Patients discharged to rehabilitation (including inpatient rehabilitation service), nursing or supported care services, or another hospital, or not discharged should be excluded
Diagnostic procedures, e.g., endoscopy, diagnostic laparoscopy (without appendicectomy)
Multivisceral resections (defined as operations involving 2 or more distinct procedures of the gastrointestinal, hepatopancreatobiliary, genitourinary, or gynaecological systems e.g. hysterectomy with colorectal resection or any other operation where multiple eligible procedures are included) [to ensure the included standard procedures are internally consistent]
Each individual patient should only be included once in the OPERAS study. Return to theatre during the same admission is regarded as a complication and should not form a duplicate entry onto REDCap.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to characterise the quantity of prescribed and consumer opioids in oral morphine equivalents (OME); these data will be stratified by procedure. Normally distributed data will be reported as mean (standard deviation (SD), and non-normally distributed data as median (interquartile range (IQR)). Independent t-tests or ANOVAs for normally distributed variables, Mann-Whitney U and Kruskal-Wallis tests for non-normally distributed continuous or ordinal variables, and chi-squared tests for categorical variables will be used for comparisons.

Multivariable, mulilevel, mixed-effects linear regression model will be conducted to assess the association between quantity of prescribed opioids to consumed opioids; this will be risk-adjusted for confound factors such as age, sex, smoking status, alcohol use, cancer, obesity, ASA grade, elective vs emergency surgery, and patient reported pain scores.

Risk factors for unused opiates at 7-days, requirements for further analgesia, and pain-related readmissions within 7-days will also be investigated using a multivariable, mixed effects logistic regression model. Hospitals will comprise the random effect in the above multivariable models.

No comparisons of data will be completed between individual sites. However, regional differences at the state- and country-level will be made to describe variations in practice. P-value < 0.05 is considered
significant.

A planned subgroup analysis will be completed of patients taking preoperative opiates.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
4/04/2022
Date of last participant enrolment
Anticipated
10/07/2022
Actual
4/09/2022
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
1000
Accrual to date
Final
5000
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 25609 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 25610 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment hospital [3] 25611 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [4] 25612 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [5] 25613 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 25614 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [7] 25615 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 25616 0
Bunbury Hospital - Bunbury
Recruitment hospital [9] 25617 0
Casey Hospital - Berwick
Recruitment hospital [10] 25618 0
Central Gippsland Health Service (Sale) - Sale
Recruitment hospital [11] 25619 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [12] 25620 0
Frankston Hospital - Frankston
Recruitment hospital [13] 25621 0
Geraldton Hospital - Geraldton
Recruitment hospital [14] 25622 0
Gold Coast University Hospital - Southport
Recruitment hospital [15] 25623 0
Gosford Hospital - Gosford
Recruitment hospital [16] 25624 0
Goulburn Base Hospital - Goulburn
Recruitment hospital [17] 25625 0
Ipswich Hospital - Ipswich
Recruitment hospital [18] 25626 0
John Hunter Hospital - New Lambton
Recruitment hospital [19] 25627 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [20] 25628 0
Logan Hospital - Meadowbrook
Recruitment hospital [21] 25629 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [22] 25630 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [23] 25631 0
Maroondah Hospital - Ringwood East
Recruitment hospital [24] 25632 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [25] 25633 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [26] 25634 0
The Northern Hospital - Epping
Recruitment hospital [27] 25635 0
NSW Ambulance Aeromedical Operations- Orange Base - Huntley
Recruitment hospital [28] 25636 0
Orange Health Service - Orange
Recruitment hospital [29] 25637 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [30] 25638 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [31] 25639 0
Royal Perth Hospital - Perth
Recruitment hospital [32] 25640 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [33] 25641 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [34] 25642 0
Bega District Hospital - Bega
Recruitment hospital [35] 25643 0
St John of God Midland Public Hospital - Midland
Recruitment hospital [36] 25644 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [37] 25645 0
Whyalla Hospital - Whyalla
Recruitment hospital [38] 25646 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [39] 25647 0
Westmead Hospital - Westmead
Recruitment hospital [40] 25648 0
Western Hospital - Footscray - Footscray
Recruitment hospital [41] 25649 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [42] 25650 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [43] 25651 0
The Canberra Hospital - Garran
Recruitment hospital [44] 25652 0
The Alfred - Melbourne
Recruitment hospital [45] 25653 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [46] 25654 0
Hedland Health Campus - South Hedland
Recruitment hospital [47] 25655 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 41434 0
2640 - Albury
Recruitment postcode(s) [2] 41435 0
3690 - Wodonga
Recruitment postcode(s) [3] 41436 0
6112 - Armadale
Recruitment postcode(s) [4] 41437 0
2350 - Armidale
Recruitment postcode(s) [5] 41438 0
3084 - Heidelberg
Recruitment postcode(s) [6] 41439 0
3350 - Ballarat Central
Recruitment postcode(s) [7] 41440 0
3128 - Box Hill
Recruitment postcode(s) [8] 41441 0
6230 - Bunbury
Recruitment postcode(s) [9] 41442 0
3806 - Berwick
Recruitment postcode(s) [10] 41443 0
3850 - Sale
Recruitment postcode(s) [11] 41444 0
5042 - Bedford Park
Recruitment postcode(s) [12] 41445 0
3199 - Frankston
Recruitment postcode(s) [13] 41446 0
6530 - Geraldton
Recruitment postcode(s) [14] 41447 0
4215 - Southport
Recruitment postcode(s) [15] 41448 0
2250 - Gosford
Recruitment postcode(s) [16] 41449 0
2580 - Goulburn
Recruitment postcode(s) [17] 41450 0
4305 - Ipswich
Recruitment postcode(s) [18] 41451 0
2305 - New Lambton
Recruitment postcode(s) [19] 41452 0
3844 - Traralgon
Recruitment postcode(s) [20] 41453 0
4131 - Meadowbrook
Recruitment postcode(s) [21] 41454 0
5112 - Elizabeth Vale
Recruitment postcode(s) [22] 41455 0
2430 - Taree
Recruitment postcode(s) [23] 41456 0
3135 - Ringwood East
Recruitment postcode(s) [24] 41457 0
3168 - Clayton
Recruitment postcode(s) [25] 41458 0
2086 - Frenchs Forest
Recruitment postcode(s) [26] 41459 0
3076 - Epping
Recruitment postcode(s) [27] 41460 0
2800 - Huntley
Recruitment postcode(s) [28] 41461 0
4108 - Coopers Plains
Recruitment postcode(s) [29] 41462 0
5000 - Adelaide
Recruitment postcode(s) [30] 41463 0
6000 - Perth
Recruitment postcode(s) [31] 41464 0
2050 - Camperdown
Recruitment postcode(s) [32] 41465 0
6009 - Nedlands
Recruitment postcode(s) [33] 41466 0
2550 - Bega
Recruitment postcode(s) [34] 41467 0
6056 - Midland
Recruitment postcode(s) [35] 41468 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [36] 41469 0
5600 - Whyalla
Recruitment postcode(s) [37] 41470 0
5006 - North Adelaide
Recruitment postcode(s) [38] 41471 0
2145 - Westmead
Recruitment postcode(s) [39] 41472 0
3011 - Footscray
Recruitment postcode(s) [40] 41473 0
3050 - Parkville
Recruitment postcode(s) [41] 41474 0
5011 - Woodville
Recruitment postcode(s) [42] 41475 0
2605 - Garran
Recruitment postcode(s) [43] 41476 0
3004 - Melbourne
Recruitment postcode(s) [44] 41477 0
4575 - Birtinya
Recruitment postcode(s) [45] 41478 0
6722 - South Hedland
Recruitment postcode(s) [46] 41479 0
2560 - Campbelltown
Recruitment outside Australia
Country [1] 24151 0
New Zealand
State/province [1] 24151 0
Country [2] 25821 0
Algeria
State/province [2] 25821 0
Country [3] 25822 0
Colombia
State/province [3] 25822 0
Country [4] 25823 0
Egypt
State/province [4] 25823 0
Country [5] 25824 0
Greece
State/province [5] 25824 0
Country [6] 25825 0
Iraq
State/province [6] 25825 0
Country [7] 25826 0
Italy
State/province [7] 25826 0
Country [8] 25827 0
Jordan
State/province [8] 25827 0
Country [9] 25828 0
Libyan Arab Jamahiriya
State/province [9] 25828 0
Country [10] 25829 0
Lithuania
State/province [10] 25829 0
Country [11] 25830 0
Malaysia
State/province [11] 25830 0
Country [12] 25831 0
Mexico
State/province [12] 25831 0
Country [13] 25832 0
Nigeria
State/province [13] 25832 0
Country [14] 25833 0
Pakistan
State/province [14] 25833 0
Country [15] 25834 0
Palestinian Territory, Occupied
State/province [15] 25834 0
Country [16] 25835 0
Romania
State/province [16] 25835 0
Country [17] 25836 0
Russian Federation
State/province [17] 25836 0
Country [18] 25837 0
Saudi Arabia
State/province [18] 25837 0
Country [19] 25838 0
Spain
State/province [19] 25838 0
Country [20] 25839 0
Sudan
State/province [20] 25839 0
Country [21] 25840 0
Syrian Arab Republic
State/province [21] 25840 0
Country [22] 25841 0
Tunisia
State/province [22] 25841 0
Country [23] 25842 0
Turkey
State/province [23] 25842 0
Country [24] 25843 0
United States of America
State/province [24] 25843 0

Funding & Sponsors
Funding source category [1] 309783 0
Self funded/Unfunded
Name [1] 309783 0
No funding to date.
Country [1] 309783 0
Primary sponsor type
Individual
Name
Associate Professor Peter Pockney
Address
G7 Newcastle Private Medical Suites, Lookout Road New Lambton
Heights NSW 2310
Country
New Zealand
Secondary sponsor category [1] 310813 0
None
Name [1] 310813 0
Address [1] 310813 0
Country [1] 310813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309534 0
Hunter New England Local Health District; Hunter New England Human Research Ethics Committee.
Ethics committee address [1] 309534 0
Ethics committee country [1] 309534 0
Australia
Date submitted for ethics approval [1] 309534 0
21/09/2021
Approval date [1] 309534 0
03/03/2022
Ethics approval number [1] 309534 0

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

Contacts
Principal investigator
Name 114490 0
A/Prof Peter Pockney
Address 114490 0
G7 Newcastle Private Medical Suites, Lookout Road New Lambton
Heights NSW 2310
Country 114490 0
Australia
Phone 114490 0
+61 0437 697 777
Fax 114490 0
Email 114490 0
peter.pockney@newcastle.edu.au
Contact person for public queries
Name 114491 0
Chris Varghese
Address 114491 0
2 Park Road,
Department of Surgery
University of Auckland
Auckland, 1023
New Zealand
Country 114491 0
New Zealand
Phone 114491 0
+64 220104993
Fax 114491 0
Email 114491 0
cvar706@aucklanduni.ac.nz
Contact person for scientific queries
Name 114492 0
Chris Varghese
Address 114492 0
2 Park Road,
Department of Surgery
University of Auckland
Auckland, 1023
New Zealand
Country 114492 0
New Zealand
Phone 114492 0
+64 220104993
Fax 114492 0
Email 114492 0
cvar706@aucklanduni.ac.nz

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13385Study protocol    382858-(Uploaded-19-10-2021-19-47-48)-Study-related document.pdf
13386Statistical analysis plan    Section 10; analysis plan in protocol.
13387Informed consent form    Will be available from: https://anzsurgsocs.org/ta... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOpioid PrEscRiptions and usage After Surgery (OPERAS): protocol for a prospective multicentre observational cohort study of opioid use after surgery.2022https://dx.doi.org/10.1136/bmjopen-2022-063577
N.B. These documents automatically identified may not have been verified by the study sponsor.