What is the effectiveness of an epidural painmanagement compared with a PCA method as postoperative treatment after an epiphysiodesis for adolescents during the first 5 days after the procedure?
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the VAS (visual analoge scores) for pain during the
first 5 days after the procedure.
Secondary outcome
Secundary outcome measures are: amount of pain 2 weeks , 6 weeks and 6 months
after the procedure; co-medication use; adverse events; satisfaction rate of
the patient; duration of Hospital stay and knee function.
Background summary
An epiphysiodesis of the knee is a frequently performed procedure for
adolescents in Maxima MC. Since three year both departments of Orthopedic
surgery of Maxima MC and Catharina Hospital has formed one membership, and as
consequent from this there are two different postoperatiev pain management
protocls active. Namely a) an epidural pain protocol and b) a PCA (pain pump).
Both painmanagement protocol will be compared.
Study objective
What is the effectiveness of an epidural painmanagement compared with a PCA
method as postoperative treatment after an epiphysiodesis for adolescents
during the first 5 days after the procedure?
Study design
open-labeled randomized clinical trial
Intervention
a) epidural painmanagement will be started at the beginning of the surgical
procedure and will be in situ for three days. Thereafter painmedication will be
prescribed according to the WHO; b) painmanagement with the use of a PCA (pain
pump) started directly after the surgical procedure, eventually oral medication
according to the WHO will be given.
Study burden and risks
Both pain management protocols are currently used in Maxima MC. The VAS is used
as standard evaluation tool during the Hospital period. During the standard
visits of the outpatient clinic we ask additional time of the patient to fill
in two questionnaires.
ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
age between12-16 year; *indicated for an epiphysiodesis*, namele boys of which the estimated finally body length will be minimally 200 cm; and for girls 195 cm.
Exclusion criteria
insufficient command of Dutch language; not willing to be randomized; contra-indications for an epiphysiodesis procedure.
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-000870-36-NL |
| CCMO | NL50837.015.15 |
| OMON | NL-OMON24503 |