None listed
Conditions
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.
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 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.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed