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LABELLO II: Single shots and ropivacaine levels.

Local analgesia in total knee replacement: The effect of local analgesia shots on ropivacaine levels in shed blood collected with a retransfusion device and in patients plasma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22415
Enrollment
20
Registered
2010-12-30
Start date
2011-01-01
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

totale knie vervanging, total knee replacement, osteoartrose, osteoarthritis, lokale pijnstilling, local analgesia

Interventions

Patients will be treated with three single local analgesia shots with ropivacaine during the operation. After the operation, blood samples en shed blood will be analysed on total and free ropivacaine

Sponsors

MC Haaglanden
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients planned for primary TKR who are clinically able to undergo such a procedure; 2. Patients must have pre-operative haemoglobin levels above 7.5 mmol/L; 3. Patients will be operated under spinal anaesthesia; 4. Male and non-pregnant female patients between 18-90 years of age; 5. Patients with BMI <40; 6. Patients are able to have a venous cannula in both arms; 7. Patients with moderate renal function (MDRD 30-50mL/min).

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.

Design outcomes

Primary

MeasureTime frame
1. Ropivacaine levels in the shed blood collected with Bellovac ABT; 2. Ropivacaine levels in the circulating blood of the patient.

Secondary

MeasureTime frame
1. VAS pain scores per hospital protocol; 2. Opioid consumption (amount of morphine used with PCA pump) 24, 48 and 72hrs; 3. Several important time points will be documented: Start operation, injection of single shot, tourniquet release, leaving recovery and blood samples; 4. Muscle power according to MRC.

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)