Reduction of the postoperative pain in Total Knee Arthroplatia through the use of a peri- and intracticular injection of Local Infiltration Analgesia.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VAS-score 6 hours after operation
Secondary outcome
Pain management: need for opiates in the first 24 hours, incidence of severe
pain (NRS >7) in the first 24 hours, VAS-score whilest leaving recovery, the
evening after surgery and the first 4 days measured 3 times a day. Side
effects: incidence and severity of nausea and vometing
Recovery: MILAS assistance scale, flexion of knee, hospital stay
Background summary
Total Knee Arthroplastia is a surgery that involves significant postoperative
pain. The aim is an optimal postoperative pain management. Local Infiltration
Analgesia (LIA) is a method that is becoming more and more standard care in
preventing and reducing this postoperative pain.
Study objective
Reduction of the postoperative pain in Total Knee Arthroplatia through the use
of a peri- and intracticular injection of Local Infiltration Analgesia.
Study design
Double-blinded, randomised, monocentre study
Intervention
Controlgroup: standard care: Peroperative placebo infiltration, postoperative
Patient Controlled Analgesia (PCA) with morfine during 20 hours.
Interventiongroup: peroperative peri- en intraarticular Local infiltratiion
Analgesia (LIA) with ropivacaïne and adrenaline, postoperative: PCA with
morfine during the first 20 hours.
Study burden and risks
The LIA-technique is standard care in several international hospitals. The
safety of the method is already demonstrated. However, in these studies
additional medication is used that is not registered in Holland. Or the
technique is compared to a technique not used in the Meander MC.
Because ropivacaine and adrenaline are already long in the market, unknown
side-effects are not expected.
Patients don't get additional interventions, no longer surgeries, no additional
questionnaires and no extra discomfort other than that they would get when not
participating in the study
There are no patients participating who are minor or incompetent.
Postbus 1502
3800 PB Amersfoort
NL
Postbus 1502
3800 PB Amersfoort
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
Total knee arthroplastia of one knee
Short track program
Exclusion criteria
revision of former total knee arthroplastia, chronic use of opioids, use of steroids, bilateral surgery, contra-indication for spinal or epidural analgesia, ASA-score > 3, time of surgery > 2 hours, intolerance of study medication, epilepsia, sensibility disorder of the leg, former patellectomy, (acute of chronic) infection of the knee, psychiatric illness, neuromuscular effects, language barrier, immunologic disease, BMI > 40, alcohol abusus, pregnant women,
Design
Recruitment
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 |
|---|---|
| CCMO | NL35559.100.11 |