ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

Pain management

Surgery

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]

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]

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]

7-days post-discharge

Secondary outcome [1]

Quality of life via EQ5D-5L

Timepoint [1]

7-days post-discharge

Secondary outcome [2]

Postoperative pain scale via the numeric rating scale

Timepoint [2]

7-days post-discharge

Secondary outcome [3]

Adequacy of pain relief prescribed via telephone questionnaire

Timepoint [3]

7-days post-discharge

Secondary outcome [4]

Requirement for further analgesia via telephone questionnaire

Timepoint [4]

7-days post-discharge

Secondary outcome [5]

Hospital readmissions for opiate-related side-effects or pain related to surgical pathology/procedure - collected via telephone questionnaire

Timepoint [5]

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?

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]

Albury Wodonga Health - Albury campus - Albury

Recruitment hospital [2]

Albury Wodonga Health - Wodonga campus - Wodonga

Recruitment hospital [3]

Armadale Kelmscott Memorial Hospital - Armadale

Recruitment hospital [4]

Armidale Rural Referral Hospital - Armidale

Recruitment hospital [5]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [6]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment hospital [7]

Box Hill Hospital - Box Hill

Recruitment hospital [8]

Bunbury Hospital - Bunbury

Recruitment hospital [9]

Casey Hospital - Berwick

Recruitment hospital [10]

Central Gippsland Health Service (Sale) - Sale

Recruitment hospital [11]

Flinders Medical Centre - Bedford Park

Recruitment hospital [12]

Frankston Hospital - Frankston

Recruitment hospital [13]

Geraldton Hospital - Geraldton

Recruitment hospital [14]

Gold Coast University Hospital - Southport

Recruitment hospital [15]

Gosford Hospital - Gosford

Recruitment hospital [16]

Goulburn Base Hospital - Goulburn

Recruitment hospital [17]

Ipswich Hospital - Ipswich

Recruitment hospital [18]

John Hunter Hospital - New Lambton

Recruitment hospital [19]

Latrobe Regional Hospital - Traralgon

Recruitment hospital [20]

Logan Hospital - Meadowbrook

Recruitment hospital [21]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [22]

Manning Rural Referral Hospital (Taree) - Taree

Recruitment hospital [23]

Maroondah Hospital - Ringwood East

Recruitment hospital [24]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [25]

The Northern Beaches Hospital - Frenchs Forest

Recruitment hospital [26]

The Northern Hospital - Epping

Recruitment hospital [27]

NSW Ambulance Aeromedical Operations- Orange Base - Huntley

Recruitment hospital [28]

Orange Health Service - Orange

Recruitment hospital [29]

Queen Elizabeth II Jubilee Hospital - Coopers Plains

Recruitment hospital [30]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [31]

Royal Perth Hospital - Perth

Recruitment hospital [32]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [33]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [34]

Bega District Hospital - Bega

Recruitment hospital [35]

St John of God Midland Public Hospital - Midland

Recruitment hospital [36]

Wyong Public Hospital - Hamlyn Terrace

Recruitment hospital [37]

Whyalla Hospital - Whyalla

Recruitment hospital [38]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [39]

Westmead Hospital - Westmead

Recruitment hospital [40]

Western Hospital - Footscray - Footscray

Recruitment hospital [41]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [42]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [43]

The Canberra Hospital - Garran

Recruitment hospital [44]

The Alfred - Melbourne

Recruitment hospital [45]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [46]

Hedland Health Campus - South Hedland

Recruitment hospital [47]

Campbelltown Hospital - Campbelltown

Recruitment postcode(s) [1]

2640 - Albury

Recruitment postcode(s) [2]

3690 - Wodonga

Recruitment postcode(s) [3]

6112 - Armadale

Recruitment postcode(s) [4]

2350 - Armidale

Recruitment postcode(s) [5]

3084 - Heidelberg

Recruitment postcode(s) [6]

3350 - Ballarat Central

Recruitment postcode(s) [7]

3128 - Box Hill

Recruitment postcode(s) [8]

6230 - Bunbury

Recruitment postcode(s) [9]

3806 - Berwick

Recruitment postcode(s) [10]

3850 - Sale

Recruitment postcode(s) [11]

5042 - Bedford Park

Recruitment postcode(s) [12]

3199 - Frankston

Recruitment postcode(s) [13]

6530 - Geraldton

Recruitment postcode(s) [14]

4215 - Southport

Recruitment postcode(s) [15]

2250 - Gosford

Recruitment postcode(s) [16]

2580 - Goulburn

Recruitment postcode(s) [17]

4305 - Ipswich

Recruitment postcode(s) [18]

2305 - New Lambton

Recruitment postcode(s) [19]

3844 - Traralgon

Recruitment postcode(s) [20]

4131 - Meadowbrook

Recruitment postcode(s) [21]

5112 - Elizabeth Vale

Recruitment postcode(s) [22]

2430 - Taree

Recruitment postcode(s) [23]

3135 - Ringwood East

Recruitment postcode(s) [24]

3168 - Clayton

Recruitment postcode(s) [25]

2086 - Frenchs Forest

Recruitment postcode(s) [26]

3076 - Epping

Recruitment postcode(s) [27]

2800 - Huntley

Recruitment postcode(s) [28]

4108 - Coopers Plains

Recruitment postcode(s) [29]

5000 - Adelaide

Recruitment postcode(s) [30]

6000 - Perth

Recruitment postcode(s) [31]

2050 - Camperdown

Recruitment postcode(s) [32]

6009 - Nedlands

Recruitment postcode(s) [33]

2550 - Bega

Recruitment postcode(s) [34]

6056 - Midland

Recruitment postcode(s) [35]

2259 - Hamlyn Terrace

Recruitment postcode(s) [36]

5600 - Whyalla

Recruitment postcode(s) [37]

5006 - North Adelaide

Recruitment postcode(s) [38]

2145 - Westmead

Recruitment postcode(s) [39]

3011 - Footscray

Recruitment postcode(s) [40]

3050 - Parkville

Recruitment postcode(s) [41]

5011 - Woodville

Recruitment postcode(s) [42]

2605 - Garran

Recruitment postcode(s) [43]

3004 - Melbourne

Recruitment postcode(s) [44]

4575 - Birtinya

Recruitment postcode(s) [45]

6722 - South Hedland

Recruitment postcode(s) [46]

2560 - Campbelltown

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

Algeria

State/province [2]

Country [3]

Colombia

State/province [3]

Country [4]

Egypt

State/province [4]

Country [5]

Greece

State/province [5]

Country [6]

Iraq

State/province [6]

Country [7]

Italy

State/province [7]

Country [8]

Jordan

State/province [8]

Country [9]

Libyan Arab Jamahiriya

State/province [9]

Country [10]

Lithuania

State/province [10]

Country [11]

Malaysia

State/province [11]

Country [12]

Mexico

State/province [12]

Country [13]

Nigeria

State/province [13]

Country [14]

Pakistan

State/province [14]

Country [15]

Palestinian Territory, Occupied

State/province [15]

Country [16]

Romania

State/province [16]

Country [17]

Russian Federation

State/province [17]

Country [18]

Saudi Arabia

State/province [18]

Country [19]

Spain

State/province [19]

Country [20]

Sudan

State/province [20]

Country [21]

Syrian Arab Republic

State/province [21]

Country [22]

Tunisia

State/province [22]

Country [23]

Turkey

State/province [23]

Country [24]

United States of America

State/province [24]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

No funding to date.

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Local Health District; Hunter New England Human Research Ethics Committee.

Ethics committee address [1]

1 Reserve Road
St Leonards NSW 2065
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/09/2021

Approval date [1]

03/03/2022

Ethics approval number [1]

Summary

Brief summary

Pain relief is considered a fundamental right in medicine. With over 80% of patients reporting pain after surgical procedures, adequate postoperative analgesia is essential to patient care. However, pain management is complex and requires the consideration of many factors including the specific surgical procedure, patients’ needs, and their perceived analgesic control.
Opioid prescriptions for non-cancer-related indications, including postoperative reasons, have been increasing in recent years. While often effective for acute pain, opioids are addictive and have numerous side effects, the most serious being respiratory depression. In the United States, there are 530 opioid-related deaths every week and the opioid epidemic has been recognized as a public health emergency. The many nonfatal health consequences of opioid abuse and addiction in Australia contribute to an annual cost of $15.7 billion. In Australia, opioid-related deaths in adults between 15-64 years of age have increased by 3.8% per year since 2007. In New Zealand, the figures are similar, with the rate of opioid-related deaths increasing by one-third in total from 2001 to 2012.
Globally, the overprescription of opioids after common surgical procedures is a well-recognized contributor to the opioid epidemic, including in Australia. Opioid initiation post-surgical hospital visit leads to chronic use in a small but significant proportion of patients. Similarly, there are a wide variety of reasons for overprescribing. Awareness of opioid prescription practices locoregionally can advise targeted interventions to change prescribing patterns and reduce the overprescribing of postoperative discharge opioids.
The aim of this prospective multi-centre cohort study is to describe the correlation between discharge opioid prescriptions to consumption by patients after common surgical procedures and the impact on patient-reported outcomes.

Trial website

https://anzsurgsocs.org/tasman/operas-study-hub/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Peter Pockney

Address

G7 Newcastle Private Medical Suites, Lookout Road New Lambton
Heights NSW 2310

Country

Australia

Phone

+61 0437 697 777

Fax

[email protected]

Contact person for public queries

Name

Chris Varghese

Address

2 Park Road,
Department of Surgery
University of Auckland
Auckland, 1023
New Zealand

Country

New Zealand

Phone

+64 220104993

Fax

[email protected]

Contact person for scientific queries

Name

Chris Varghese

Address

2 Park Road,
Department of Surgery
University of Auckland
Auckland, 1023
New Zealand

Country

New Zealand

Phone

+64 220104993

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
13385	Study protocol		382858-(Uploaded-19-10-2021-19-47-48)-Study-related document.pdf
13386	Statistical analysis plan	Section 10; analysis plan in protocol.
13387	Informed 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

Source	Title	Year of Publication	DOI
Embase	Opioid PrEscRiptions and usage After Surgery (OPERAS): protocol for a prospective multicentre observational cohort study of opioid use after surgery.	2022	https://dx.doi.org/10.1136/bmjopen-2022-063577

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically