*Local anaesthetic in total knee replacement: quantification of local anaesthetic in retransfusable blood-tissue fluid collected with a Bellovac ABT system and in plasma.*
Completed
- Conditions
- joint wear (osteoarthritis)own blood donation (autologous blood transfusion)10023213
- Registration Number
- NL-OMON33633
- Lead Sponsor
- Medisch Centrum Haaglanden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- primary TKP
- HB level above 7.5 mmol/L
- ASA I-II
- both arms can be used for blood collection
Exclusion Criteria
- allergic for used medication or othe local anaesthetics
- major operation within 12 weeks before TKP surgery
- high risk patients for insultus epilepticus.
- dutch language not mastered
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Ropivacaine will be quantified in patient serum (0, 3, 6 and 24 h after<br /><br>surgery) and in the blood and tissue fluid collected and filtered in the<br /><br>Bellovac ABT system in order to be able to calculate systemic exposure after<br /><br>reinfusion of the blood.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* VAS pain scores pre, 6hrs, 12hrs and 24hrs<br /><br>* Opioid consumption (amount of morfine used with PCA pump) 24, 48 and 72hrs<br /><br>* Several important time points will be documented; start operation, injection<br /><br>of single shot, tourniquet release, leaving recovery and blood samples </p><br>