No registrations found.
ID
Source
Brief title
Health condition
total knee arthroplasty, retransfusion, local anesthesia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ropivacaine will be quantified in patient serum (0, 3, 6 and 24 h after surgery) and in the blood-tissue fluid collected and filtered in the Bellovac ABT system in order to be able to calculate systemic exposure after reinfusion of the blood.
Secondary outcome
VAS painscores.
Background summary
Evidence suggests that local anaesthesia after total knee replacement (TKR) provides better knee function in the postoperative period with less post-operative complications like nausea and vomiting as compared to conventional ways of pain treatment (i.e.opioids). Good clinical results have been obtained with and without the use of indwelling catheters. The Bellovac ABT system; a technique to collect, filter and reinfuse blood and tissue fluid, is also often used in TKR. Bellovac ABT is used as an alternative to allogeneic blood transfusion. A combination of both techniques however, is not common yet. Before routinely combining local anaesthesia with the Bellovac technique we want to quantify the amount of local anaesthetic (if any) in the collected and retranfusable blood and tissue fluid. On the basis of these data the safety of combining local anaesthesia with the retransfusion of blood and tissue fluid will be assessed.
Study objective
To quantify the amount of local anaesthetic in blood and tissue fluid in the Bellovac ABT system and in the blood circulation of the patient. The primary objective is to quantify the cumulative ropivacaine level when the blood should be retransfused to the patient. As a secondary objective the quality of postoperative anaesthesia will be evaluated.
Study design
During hospitalisation.
Intervention
Administration of local anaesthetic (single shot and continuous infusion) in TKR. Blood and tissue fluid will be collected in a Bellovac ABT system and by venous sampling and used for quantification of local anaesthetics.
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Inclusion criteria
1. Patients must have pre-operative haemoglobin levels above 7.5 mmol/L;
2. Patients will be operated under spinal anaesthesia;
3. Male and non-pregnant female patients between 18-90 years of age;
4. Patients with BMI <40;
5. Patients are able to have a venous cannula in both arms;
6. Patients have normal renal function for their age (MDRD);
7. ASA classification score I-II.
Exclusion criteria
1. Patients with a major surgical procedure during the 12 weeks before the study-related operation;
2. Patients with documented allergy for the medication (ropivacaine, bupivacaine, NSAIDs, aminoacetophen or opiates) used in the study or any other local anaesthetic of the amino amide type;
3. Recent Myocardial Infarction or CVA (<3 months);
4. Patients with elevated risk of epileptic seizures;
5. Dutch language not mastered.
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 |
---|---|
NTR-new | NL1683 |
NTR-old | NTR1784 |
Other | METC Medical Center Haaglanden : 08-132 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |