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Local anaesthesia and Bellovac ABT.

‘Local anaesthesia in total knee replacement: quantification of local anaesthetic in retransfusable blood-tissue fluid collected with a Bellovac ABT system and in plasma.’

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22267
Enrollment
20
Registered
2009-04-28
Start date
2009-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

total knee arthroplasty, retransfusion, local anesthesia

Interventions

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 o

Sponsors

Medical Center Haaglanden, the Hague
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
VAS painscores.

Contacts

Public ContactB.J.W. Thomassen

Haaglanden Medical Center PO Box 432

b.thomassen@mchaaglanden.nl+31 (0)70 3303109

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)