Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000632796
Ethics application status
Approved
Date submitted
9/03/2022
Date registered
28/04/2022
Date last updated
30/08/2024
Date data sharing statement initially provided
28/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Opioid Requirements After Discharge following Surgery
Scientific title
Opioid Requirements After Discharge following Surgery
Secondary ID [1] 306646 0
None
Universal Trial Number (UTN)
Trial acronym
ORADS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Pain 325575 0
Opioid misuse 325576 0
Condition category
Condition code
Anaesthesiology 322945 322945 0 0
Pain management
Surgery 322982 322982 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
Participants will be followed-up once only at one week after the participant is discharged home following surgery. They will be sent a SMS link to an online survey for completion on their smart phone. Alternatively, participants will be able to complete the survey by phone with a research nurse. The survey will take approximately 5 minutes to complete.
The survey will examine:
1) The amount of discharge opioid that was used during the first week following discharge from hospital.
2) The amount of non opioid analgesics used during the first week following discharge from hospital.
3) Additional opioids used during the first week following discharge from hospital.
4) The source of any additional opioids (already at home, from a health professional)
5) Pain crises
6) Whether they saw a general practitioner, hospital or other health provider for pain relief.
7) What education they received about pain relief while in hospital before discharge home.
Intervention code [1] 323088 0
Diagnosis / Prognosis
Comparator / control treatment
The outcomes will be assessed across 32 common types of surgery that cover a wide variety of surgical specialities.
These types of surgery include:
Hip arthroplasty
Knee arthroplasty
Wrist ORIF
Ankle ORIF
Knee arthroscopy
Shoulder repair
LSCS
Open hysterectomy
Vaginal/lap hysterectomy
Vaginal repairs
Minor laparoscopic
Total/bilateral mastectomy
Partial mastectomy / lumpectomy
Hemi/total thyroidectomy
Cardiac with sternotomy
Thoracic
Sinus surgery
Parotidectomy
Middle ear surgery (not Grommets)
Laparotomy
Perianal/pilonidal procedures
Lap cholecystectomy
Lap bowel resection
Lap fundoplication/sleeve/bypass
Hernia repair (non-gastric) - open
Hernia repair (non-gastric) - laparoscopic
Spinal
Craniotomy
Breast reduction
Abdominoplasty
Ureteric stent placement
TURP
Nephrectomy
Prostatectomy
Control group
Active

Outcomes
Primary outcome [1] 330710 0
The total amount of discharge opioids consumed in the first week following discharge home after surgery. Measured by either an online smart phone survey or via a phone call with a research nurse.
Timepoint [1] 330710 0
One week post-hospital discharge
Primary outcome [2] 330711 0
Pain crises assessed by either an online smart phone survey or via a phone call with a research nurse. Pain crises will be defined as either:
1) Participant required extra pain relief from an emergency department/health provider
2) Severe pain without help, "At any time were you in severe pain that you were not able to manage and you weren't able to access help?"
Timepoint [2] 330711 0
One week post-hospital discharge
Secondary outcome [1] 407274 0
Patients' perception of the amount of discharge opioids that was prescribed for them.
Assessed by a survey via either an online smart phone or via a phone call with a research nurse.
"Do you feel that your discharge script amount was:"
a. More than I needed
b. About right
c. Less than I needed
Timepoint [1] 407274 0
One week post-hospital discharge
Secondary outcome [2] 407275 0
Education received in hospital about pain management when at home. Assessed by a survey via either an online smart phone or via a phone call with a research nurse.
"Before you left hospital, did someone…"
Matrix – checkbox (single) Yes/No for each
a. Explain what your pain medication was for?
b. Explain how to take the medication?
c. Explain the side effects?
e. Explain what you should do if your pain did not resolve?
f. Explain what to do with left over medication?
g. Was this information provided in writing?

"Before you left hospital, who spoke to you about how to use pain relief?
(If you can’t remember, leave blank)"
a. Nurse
b. Pharmacist
c. Doctor

"Do you wish that you received:"
checkbox (single)
a. More education
b. Was about right
c. Less education
Timepoint [2] 407275 0
One week post-hospital discharge
Secondary outcome [3] 408584 0
In-patient opioid consumption (oral oxycodone equivalent dose in mg) during the 24 hours before discharge home for participants who stayed at least one night in hospital following their surgery. Assessed by electronic medical records.
Timepoint [3] 408584 0
At discharge home from hospital

Eligibility
Key inclusion criteria
Elective surgery
Age at least 18 years
Able to give consent
Able to use a smart phone or receive a phone call
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We have identified 34 common types of surgery that occur at SALHN. The predictive model would have to generate median value and standard deviations for each type of surgery with a clinically acceptable error margin. Those values would then be adjusted for other factors.
When considering each type of surgery, the central limit theorem suggests that a sample of 30 would produce a distribution of sample means that approximates a normal distribution. Considering that our pilot study showed data that is non-linear with a bimodal distribution, a sample of 50 per surgery type would be prudent to ensure predictive value. Other factors such as age, gender, weight, chronic pain and inpatient opioid usage, would involve larger numbers so will be sufficiently powered by the calculations for surgery type.

A 80:20 data split between prediction set and validation set is planned.

The pilot study showed that 396 recruited participants produced 253 data collections (5.5% didn’t proceed to have surgery and 32% didn’t respond to the survey). Based on this response rate of 63.9%, the number of participants required is:

Initial plan was:
32 surgery types x 63 (50 completed surveys plus 25% extra for validation(50 x 1.25 = 62.5, rounded to 63)) / response rate 0.639 = 3,155 participants.

This was updated after 750 participants were enrolled:
Our survey response rate for the first 750 participants has been above 90%, well above the expected 63.9% from the pilot study. Also two extra surgery types were added (shoulder arthroscopic repairs and laparoscopic hernia repairs (non-gastric). The revised number of participants is:
34 types of surgery x 63 (50 per surgery type plus extra 20% for data validation (50 x 1.2 rounded to 63)) / response rate of 90% = 2,380.

This has been conservatively rounded to 2,500 incase the response rate is not sustained. The trial will finish when 63 completed surveys are collected for each surgery type so hopefully before 2,500 participants have been recruited.

A multi-variable regression technique will be used to produce the model that predicts opioid requirements based upon surgery type and several patient factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
20/12/2022
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
2500
Accrual to date
968
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21945 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [2] 26370 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 37035 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 310971 0
Charities/Societies/Foundations
Name [1] 310971 0
Flinders Foundation
Country [1] 310971 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Research Office
Flinders Medical Centre
Finders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 312280 0
None
Name [1] 312280 0
Address [1] 312280 0
Country [1] 312280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310529 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 310529 0
Ethics committee country [1] 310529 0
Australia
Date submitted for ethics approval [1] 310529 0
02/05/2022
Approval date [1] 310529 0
13/09/2022
Ethics approval number [1] 310529 0

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

Contacts
Principal investigator
Name 117974 0
Dr Jason Koerber
Address 117974 0
Anaesthetic Department
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 117974 0
Australia
Phone 117974 0
+61488991174
Fax 117974 0
Email 117974 0
[email protected]
Contact person for public queries
Name 117975 0
Jason Koerber
Address 117975 0
Anaesthetic Department
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 117975 0
Australia
Phone 117975 0
+61882045511
Fax 117975 0
Email 117975 0
[email protected]
Contact person for scientific queries
Name 117976 0
Jason Koerber
Address 117976 0
Anaesthetic Department
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 117976 0
Australia
Phone 117976 0
+61882045511
Fax 117976 0
Email 117976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor via discussion with the principal investigator.
Available for what types of analyses?
Potentially for any purpose but will at the discretion of the sponsor.
How or where can data be obtained?
By contacting the principal investigator, Dr Jason Koerber, who will discuss with the primary sponsor. The contact email address is [email protected]. Alternatively, phone contact can be via the Flinders Medical Centre switch, +61 8 8204 5511.


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.