To determine the resorption of ropivacaïne and serum concentration we need 6 bloodsamples at t=0, t=30 min, t=1 hour, t=2 hour, t=4 hour, t=8 hour. A pharmacokinetic model will be made for each procedure using a software package MW/Pharm © (version…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to describe the pharmacokinetic profile of
infiltrated ropivacaine. And to determine the serum concentration of
ropivacaine
Secondary outcome
Secundary outcomes:
1)Parameters that influence the absorption of local infiltrated ropivacaine
- Patientscharacteristics
- infiltrated area
- used dosage
2) Relatioship between postoperative pain and serum concentration
Background summary
In plastic surgery of the MMC, the emphasis is on the use of local anesthetics
to minimize the post-operative pain. The effective control of postoperative
pain is not only very desirable for humanitarian reasons, it is more often that
this provides significant physiological benefits.
With reducing post operative pain, is postoperative recovery faster, minimizes
clinical stay and return to work faster.
About the absorption of ropivacaine and serum concentration is limited
evidence. That is why we want to study the serum concentration of local
infiltrated ropivacaïne in venous blood.
Study objective
To determine the resorption of ropivacaïne and serum concentration we need 6
bloodsamples at t=0, t=30 min, t=1 hour, t=2 hour, t=4 hour, t=8 hour. A
pharmacokinetic model will be made for each procedure using a software package
MW/Pharm © (version 3.81).
Study design
A prospective observational pilot study.
Study burden and risks
regular care
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
> 18 years, breast reduction, abdominoplastic, local infiltration with ropivacain, endoscopic brow lift, minimal clinical stay of 1 day
Exclusion criteria
Intolerance of ropivacain, hepatic and/or renal failure, endoscopic brow lift patients who pay the operation themselves.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54819.015.15 |
| OMON | NL-OMON21531 |