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Trial registered on ANZCTR


Registration number
ACTRN12623000686606
Ethics application status
Approved
Date submitted
18/05/2023
Date registered
26/06/2023
Date last updated
19/11/2023
Date data sharing statement initially provided
26/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intrathecal morphine compared to standard care with oral and intravenous (IV) opioids on the quality of recovery after robotic-assisted radical prostatectomy
Scientific title
The effect of intrathecal morphine compared to standard care with oral and IV opioids on the quality of recovery after robotic-assisted radical prostatectomy
Secondary ID [1] 309906 0
None
Universal Trial Number (UTN)
Trial acronym
IMRARP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
 329956 0
Post-operative Pain 329957 0
Bladder Spasms 329958 0
Condition category
Condition code
Anaesthesiology 326858 326858 0 0
Anaesthetics
Anaesthesiology 326859 326859 0 0
Pain management
Anaesthesiology 326860 326860 0 0
Other anaesthesiology
Cancer 326861 326861 0 0
Prostate
Surgery 326862 326862 0 0
Other surgery
Surgery 326863 326863 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intrathecal local anaesthetic (2-3ml 0.5% bupivacaine or 0.75% ropivacaine) plus morphine 150-300 microgram (dosage to be discretion of treating anaesthetist, in response to consideration of individual patient factors and hospital-specific intrathecal morphine prescribing protocols. In addition, patients will receive standard of care which is a combination of intravenous and oral opioid perioperatively as appropriate.
Intervention code [1] 326057 0
Treatment: Drugs
Intervention code [2] 326058 0
Treatment: Other
Comparator / control treatment
Control with “Sham” spinal anaesthesia (Patient positioned and prepped for spinal anaesthesia, and subcutaneous injection of local anaesthetic only but neuraxial space not accessed and no medication administered intrathecally)
In addition, patients will receive standard of care which is a combination of intravenous and oral opioid perioperatively as appropriate.
Control group
Placebo

Outcomes
Primary outcome [1] 334711 0
The primary endpoints of this study are to determine if, compared to standard of care with intravenous and oral analgesics, the use of spinal anaesthesia with/without intrathecal morphine:
(1) Patient reported quality of recovery score (as measured by the QoR-15 scale) on postoperative day 1.
Timepoint [1] 334711 0
Post-operative day 1
Secondary outcome [1] 421829 0

(1) Oral morphine equivalent dose (OMED) in the first 24 hours post-surgery (in mg, morphine equivalency), as documented in the medical record.
Timepoint [1] 421829 0
(1) first 24 hours post-surgery
Secondary outcome [2] 422973 0
(2) Incidence of bladders spams in the post-anaesthesia care unit (PACU), as documented in the PACU record.
Timepoint [2] 422973 0
For the duration of stay in the post-anaesthetic care unit (PACU)
Secondary outcome [3] 422974 0
(3) Severity of bladders spams in PACU, to be measured using a 10-point numerical rating scale.
Timepoint [3] 422974 0
For the duration of stay in the post-anaesthetic care unit (PACU)
Secondary outcome [4] 422975 0
(4) PACU length of stay, in hours, using the medical record
Timepoint [4] 422975 0
For the duration of stay in the post-anaesthetic care unit (PACU)
Secondary outcome [5] 422976 0
(5) PACU OMED consumption, as documented in the PACU medical record.
Timepoint [5] 422976 0
For the duration of stay in the post-anaesthetic care unit (PACU)
Secondary outcome [6] 422977 0
(6) Pain scores (assessed by numerical pain scale) in the first 24 hours post-surgery (at 1hrs, 6hrs and 24hrs postoperatively), as documented in the medical record.
Timepoint [6] 422977 0
Pain scores at 1hrs, 6hrs and 24hrs postoperatively
Secondary outcome [7] 422978 0
(7) Hospital length of stay, assessed using patient medical records
Timepoint [7] 422978 0
Upon Discharge from Hospital
Secondary outcome [8] 422979 0
(8) Intrathecal morphine associated side effects such as pruritis and nausea, vomiting – to be measured on postoperative day 1 using a 10-point numerical rating scale.
Timepoint [8] 422979 0
Postoperative day 1
Secondary outcome [9] 422980 0
(9) Patient reported quality of recovery score (as measured by the Quality of recovery QoR-15 scale) on postoperative day 7.
Timepoint [9] 422980 0
Day 7 post-operation
Secondary outcome [10] 422981 0
(10) Nursing workload and satisfaction with PACU phase (numerical rating scale), assessed as a composite outcome
Timepoint [10] 422981 0
Upon patient's discharge from PACU
Secondary outcome [11] 422982 0
(11) Total duration of anaesthesia (in minutes), from the medical record
Timepoint [11] 422982 0
Total duration of anaesthesia (in minutes).

Eligibility
Key inclusion criteria
Scheduled for robotic-assisted radical prostatectomy (RARP) for the indication of prostate cancer.
Age greater or equal to 18yrs
No contraindication to neuraxial anaesthesia
No allergy to morphine
At least 1 overnight hospital stay
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Day stay RARP cases
Platelets <80
Therapeutic low molecular weight heparin (LMWH) within preceding 24hours
Prophylactic LMWH within preceding 12 hours
Antiplatelet therapy within the preceding 7 days
Other contraindication to neuraxial anaesthesia

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)
Recruited patients will be randomly assigned to one of the treatment arms by a computer-generated randomisation algorithm, in a 1:1 manner.

Only the patient will be blinded to the study intervention. The research team, treating anaesthetist, surgical team, PACU and ward nurses will not be blinded to study intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Recruited patients will be randomly assigned to one of the treatment arms by a computer-generated randomisation algorithm, in a 1:1 manner.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size:
Using a power of 80% and a type 1 error rate (alpha) of 0.05 for a two-tailed independent t test, a total sample size of 144 (72 per arm) is required detect a 10-point difference in QoR-15 score. A 10-point difference has been agreed upon after review of two published studies. One is a paper by the authors of the QoR-15 score, recommending a minimally important difference of 8. The second is a clinical trial in which patients undergoing robotic prostatectomy were randomised to receive intrathecal morphine. In this study, a difference in QoR-15 of 14 points was reported. The study will be analysed on an intention-to-treat and per-protocol basis, and as such, the sample size will be increased by 10% to account for patient crossover due to failed spinal anaesthesia. Therefore, a total sample size of 158 (79 per arm) is required for this study.

Statistical methodology.
A statistical analysis plan will be completed prior to statistician unblinding and commencement of analysis. Descriptive statistics will consist of number and percentage for categorical variables and mean and standard deviation (SD) or median and interquartile range (IQR) will be reported for continuous variables (parametric and non-parametric, respectively). The primary outcome, quality of recovery will be analysed using paired t-test (adjusting for baseline QOR-15 score) or Wilcoxon signed-rank test, dependent on whether the data are parametric or non-parametric. Secondary outcomes will be analysed by appropriate statistical method (for continuous or discrete data types, after assessment of the normality of the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
24/07/2023
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
5/07/2024
Actual
Sample size
Target
158
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24692 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 24764 0
Epworth Richmond - Richmond
Recruitment hospital [3] 25868 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 40315 0
3000 - Melbourne
Recruitment postcode(s) [2] 40396 0
3121 - Richmond
Recruitment postcode(s) [3] 41701 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 311031 0
Charities/Societies/Foundations
Name [1] 311031 0
Epworth Foundation Research Grant
Country [1] 311031 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Peter MacCallum Cancer Centre, 305 Grattan st, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 315725 0
None
Name [1] 315725 0
Address [1] 315725 0
Country [1] 315725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310579 0
Peter MacCallum Cancer Centre Human Research ethics Committee
Ethics committee address [1] 310579 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000
Ethics committee country [1] 310579 0
Australia
Date submitted for ethics approval [1] 310579 0
11/04/2023
Approval date [1] 310579 0
24/04/2023
Ethics approval number [1] 310579 0

Summary
Brief summary
This study is investigating the effect of intrathecal morphine compared to standard care with oral and intravenous opioids on the quality of recovery after robotic-assisted radical prostatectomy.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with prostate cancer, and are scheduled for robotic-assisted radical prostatectomy, and have no allergy to morphine.

Participants undergoing robotic-assisted radical prostatectomy will be randomly allocated (by chance) to one of two groups: one group will be prepared for spinal anaesthesia and receive morphine administered through spinal injection and the other group will be prepared for spinal anaesthesia but will not receive a morphine injection. Both groups will receive standard care of oral and intravenous pain medications (opioids) from admission to discharge, as appropriate.

Participants recovery, pain levels and oral morphine medications will be monitored in the first 24 hours post-surgery. Side effects will be monitored for the duration of the hospital stay.

It is hoped that this research will help improve postoperative recovery after robotic-assisted radical prostatectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118150 0
Dr Julia Dubowitz
Address 118150 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, VIC 3000
Country 118150 0
Australia
Phone 118150 0
+61411016828
Fax 118150 0
Email 118150 0
[email protected]
Contact person for public queries
Name 118151 0
Julia Dubowitz
Address 118151 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000
Country 118151 0
Australia
Phone 118151 0
+61411016828
Fax 118151 0
Email 118151 0
[email protected]
Contact person for scientific queries
Name 118152 0
Julia Dubowitz
Address 118152 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000
Country 118152 0
Australia
Phone 118152 0
+61411016828
Fax 118152 0
Email 118152 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
Individual data will not be available, pooled results will be reported in peer review journal and at conferences


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.