The primary goal is to increase the quality of recovery, as measured by the QoR-15-scale.Secundary goals are to decrease the use of systemic opiates, less bladderspasms and pain, reduce the side-effects op opiates, increase the patient-satisfaction…
ID
Source
Brief title
Condition
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
QoR-15-scale at day 1 and day 7-10.
Secondary outcome
Secundary goals are to decrease the use of systemic opiates (in mg of morfine).
Less bladderspasms and pain (both on a NRS-scale (0-10)
Reduce the side-effects op opiates (nausea, vomiting, pruritus, sedation (NRS
0-10)
Increase the patient-satisfaction (NRS 0-10), mobility (NRS 0-10) and surgical
workspace (NRS 0-10).
Background summary
The surgical method of a radical prostatectomy has changed over the past years.
At first, the Millin-procedure was associated with a lot of bloodloss and high
postoperative painscores. Today, a Robotic Assisted Radical Prostatectomy
(RARP) is associated with minimal bloodloss, a small surgical field and a quick
recovery.
These changes have consequences for the peri-opertative pain management. It
seems that many patients after RARP's suffer from severe postoperative pain,
which is largely associated with bladderspasms. Previous studies investigated
Non-Steroidal Anti-Inflammatory Drugs (NSAID's), regional anaesthesia and
anti-muscarine medication, but minimal effect was seen.
Spinal morphine would potentially inhibit both nociceptive pain as discomfort
from bladderspasms, therefore it could be of great benefit for the quality of
recovery after a RARP. This has yet to be investigated.
Other potential benefit is the decrease in the need for systemic opiates. In a
retrospective study of Biki et al. the use of systemic opiates is associated
with cancer-recurrence, potentially by the inhibition of Natural Killer-cells.
However, this association has never been reproduced in other (prospective)
studies and remains highly controversial.
Study objective
The primary goal is to increase the quality of recovery, as measured by the
QoR-15-scale.
Secundary goals are to decrease the use of systemic opiates, less bladderspasms
and pain, reduce the side-effects op opiates, increase the
patient-satisfaction, mobility and surgical workspace.
Study design
A double-blinded randomized controlled trial
Intervention
Spinal injection of bupivacaine/morphine.
Study burden and risks
A single spinal injection and three times a survey.
Gerrit van de Lindestraat 35e
Rotterdam 3022TC
NL
Gerrit van de Lindestraat 35e
Rotterdam 3022TC
NL
Listed location countries
Age
Inclusion criteria
Adults (>18 years), scheduled for RARP
Exclusion criteria
Age under 18 years old, Renal Insufficiency (MRDR <30 ml/min), Contra-indications for spinal anaesthesia (severe Aortic Valve stenosis, coagulation disorders, increased intracranial pressure), conversion to an open procedure, post-operative ICU-admission, allergies to studymedication.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-004319-20-NL |
| CCMO | NL55218.101.15 |