To evaluate the value of a TAP-block for the reduction of postoperative bladder spasm after RALP for prostate cancer
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence rate of postoperative bladder spasm at 1 hour after arrival at
the recovery room , 4 hours postoperatively and on the morning of the first
postoperative day.
Secondary outcome
Pain by NRS (0 - 10) , done one hour after arrival at the recovery room , 4
hours postoperatively and on morning of the first postoperative day.
Postoperative nausea and vomiting during the period end of the surgical
procedure till 12:00 am of the first postoperative day.
The cumulative dose of oxybutinine and butylscopolamine and morfine given
between the arrival at the recovery room and 12 am on the morning of the first
postoperative day.
Background summary
The incidence rate of bladder spasm after robot assisted laparoscopic radical
prostatectomy (RALP) under general anesthesia is high and may be 64% . The
incidence rate of bladder spasm decreases to 33% without the use of any
anti-cholinergic agent or any spasmolytic agent in patients receiving a
transversus abdominis plane-block (TAP-block) just after de induction of
anesthesia but before the start of surgery.
Study objective
To evaluate the value of a TAP-block for the reduction of postoperative bladder
spasm after RALP for prostate cancer
Study design
single blinded, placebo-controlled.
Intervention
A bilateral TAP-block is performed in patients undergoing a RALP for prostate
cancer, randomized for TAP-block.
Study burden and risks
advantage: more comfort during the postoperative period than after a standard
procedure.
disadvantage: a bilateral blood extravasation in the skin overlying Petit's
triangle such as may occur after a normal venepunction.
As is the case in any regional anesthesia technique, the local anesthetic agent
may be injected intravenously when the instructions for proper performance of a
TAP block are neglected with the ultimate consequences of an local anesthetic
intoxication.
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Men with prostate cancer scheduled for robot assisted laparoscopic radical prostatectomy (RALP)
Exclusion criteria
Mental disorders.
Inability to communicate in Dutch or English language
Re-intervention procedures after (RALP)
Conversion form RALP to an open procedure
Allergy for amide type local anesthetic agents
Allergy for oxybutinine, or butylscopolamine
Allergy to acetaminophen
Allergy to diclofenac.
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 | EUCTR2007-004799-38-NL |
| CCMO | NL19509.031.07 |