Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000901404
Ethics application status
Approved
Date submitted
24/07/2025
Date registered
19/08/2025
Date last updated
19/08/2025
Date data sharing statement initially provided
19/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of oral oxycodone versus sublingual buprenorphine for pain control after pelvic exenteration
Scientific title
A pilot, registry-embedded, multi-centre, double-blind, placebo-controlled, randomised controlled trial of oral oxycodone versus sublingual buprenorphine for postoperative pain control after pelvic exenteration
Secondary ID [1] 314991 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROSPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain and function 338316 0
Condition category
Condition code
Anaesthesiology 334606 334606 0 0
Pain management
Surgery 334747 334747 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Oxycodone 5-10 mg oral tablet + Placebo [lactose tablet] sublingual every 3 hours as needed
Arm 2: Buprenorphine 200-400 mcg sublingual tablet + Placebo [lactose tablet] oral every 3 hours as needed

Duration:
Initiated as soon as possible postoperatively and continued for up to 7 days after the first dose

Mode:
Oral and sublingual tablets

Administration:
Administered by registered nurses. Dose within range selected based on pain scores and clinical judgement. Adherence to intervention is monitored via electronic medical records.
Intervention code [1] 331581 0
Treatment: Drugs
Comparator / control treatment
Arm 1 will be used as the reference comparator arm
Arm 1 - oxycodone 5-10 mg oral tablet + placebo [lactose tablet] sublingual every 3 hours as needed. Initiated as soon as possible postoperatively and continued for up to 7 days after the first dose
Control group
Active

Outcomes
Primary outcome [1] 342288 0
Recruitment rate
Timepoint [1] 342288 0
Recruitment over a 6-month time frame
Secondary outcome [1] 450253 0
Quality-of-Recovery-15 (QoR-15)
Timepoint [1] 450253 0
Postoperative day 7 and 14. Calculated at study conclusion
Secondary outcome [2] 450254 0
Bowel recovery [bowel movement]
Timepoint [2] 450254 0
Assessed during hospitalisation. Calculated at study conclusion
Secondary outcome [3] 450255 0
Pain scores
Timepoint [3] 450255 0
Up to postoperative day 7. Calculated at study conclusion.
Secondary outcome [4] 450256 0
Protocol adherence
Timepoint [4] 450256 0
During the 7 days of study drug postoperatively. Calculated at study conclusion.
Secondary outcome [5] 450688 0
Bowel recovery [oral diet]
Timepoint [5] 450688 0
Assessed during hospitalisation. Calculated at study conclusion.
Secondary outcome [6] 450691 0
Pain function
Timepoint [6] 450691 0
Up to postoperative day 7. Calculated at study conclusion.
Secondary outcome [7] 450884 0
Acceptability of the trial
Timepoint [7] 450884 0
Postoperative day 90. Qualitative assessment at study conclusion.

Eligibility
Key inclusion criteria
-Pelvic exenteration surgery for advanced primary or recurrent pelvic (e.g., rectal, bladder, prostate, uterine, and other) malignancies
-Age 18 years or more
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-The treating clinician does not consider both drugs to be a suitable option for the patient or does not consider the trial to be in the best interests of the patient based on precautions with study drugs or previous adverse events attributed to study drugs
-Use of monoamine oxidase inhibitors (MAOI) within 14 days of planned surgery. These include: phenelzine, tranylcypromine, moclobemide, selegiline, rasagiline, linezolid.
-The treating team intends to use epidural analgesia perioperatively or if epidural analgesia is used prior to randomisation
-Unable to provide informed consent

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analyses for primary and secondary feasibility outcomes are descriptive and will be reported as proportions (n/N, %). Trends in recruitment rates will be depicted visually across sites.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2026
Actual
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 28238 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 28239 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 28240 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 44449 0
2050 - Camperdown
Recruitment postcode(s) [2] 44450 0
3000 - Melbourne
Recruitment postcode(s) [3] 44451 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 319541 0
Government body
Name [1] 319541 0
Department of Health and Aged Care (Federal)/MRFF
Country [1] 319541 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 322044 0
None
Name [1] 322044 0
Address [1] 322044 0
Country [1] 322044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318118 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 318118 0
Ethics committee country [1] 318118 0
Australia
Date submitted for ethics approval [1] 318118 0
22/05/2025
Approval date [1] 318118 0
02/07/2025
Ethics approval number [1] 318118 0
2025/ETH01058

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

Contacts
Principal investigator
Name 143170 0
Prof Asad Patanwala
Address 143170 0
Pharmacy Building (A15), The University of Sydney, NSW 2006
Country 143170 0
Australia
Phone 143170 0
+61 2 8627 7445
Fax 143170 0
Email 143170 0
[email protected]
Contact person for public queries
Name 143171 0
Asad Patanwala
Address 143171 0
Pharmacy Building (A15), The University of Sydney, NSW 2006
Country 143171 0
Australia
Phone 143171 0
+61 2 8627 7445
Fax 143171 0
Email 143171 0
[email protected]
Contact person for scientific queries
Name 143172 0
Asad Patanwala
Address 143172 0
Pharmacy Building (A15), The University of Sydney, NSW 2006
Country 143172 0
Australia
Phone 143172 0
+61 2 8627 7445
Fax 143172 0
Email 143172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.