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Local anaesthesia and Bellovac ABT.


- candidate number5669
- NTR NumberNTR1784
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2009
- Secondary IDs08-132 METC Medical Center Haaglanden
- Public TitleLocal anaesthesia and Bellovac ABT.
- Scientific Title‘Local anaesthesia in total knee replacement: quantification of local anaesthetic in retransfusable blood-tissue fluid collected with a Bellovac ABT system and in plasma.’
- ACRONYMLABELLO study
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-okt-2009
- Target number of participants20
- InterventionsAdministration 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.
- Primary outcomeRopivacaine 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 outcomeVAS painscores.
- TimepointsDuring hospitalisation.
- Trial web sitewww.mchaaglanden.nl/orthopedie
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. B.J.W. Thomassen
- CONTACT for SCIENTIFIC QUERIESDrs. B.J.W. Thomassen
- Sponsor/Initiator Medical Center Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
AstraTech Healthcare AB, Sweden
- PublicationsN/A
- Brief summaryEvidence 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.
- Main changes (audit trail)
- RECORD28-apr-2009 - 9-sep-2010


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