RecruitingACTRN12623000686606

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

The effect of intrathecal morphine compared to standard care with oral and IV opioids on the quality of recovery after robotic-assisted radical prostatectomy


Sponsor

Peter MacCallum Cancer Centre

Enrollment

158 participants

Start Date

Jul 24, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Robotic-assisted radical prostatectomy is a surgery to remove the prostate gland in men with prostate cancer. While highly effective, managing pain after this operation is important for a smooth recovery. This trial is investigating whether giving morphine through a spinal injection (intrathecal morphine) before surgery improves post-operative recovery compared to the standard approach of using oral and intravenous pain medications. Participants will be randomly allocated to receive either a spinal injection containing morphine before their surgery or a spinal preparation without morphine, followed by standard oral and IV pain relief in both cases. Researchers will track pain levels, how much additional pain medication is needed, and any side effects over the first 24 hours and throughout the hospital stay. You may be eligible if you are a man aged 18 or older with prostate cancer who is scheduled for robotic-assisted prostatectomy, have no allergy to morphine, and are expected to stay at least one night in hospital. Men who have certain blood-thinning medications on board, very low platelet counts, or other contraindications to spinal anaesthesia may not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 individua

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.


Locations(2)

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

Epworth Richmond - Richmond

VIC, Australia

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ACTRN12623000686606


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