ABELLO II: Single shots and ropivacaine levels.
Completed
- Conditions
- totale knie vervanging, total knee replacement, osteoartrose, osteoarthritis, lokale pijnstilling, local analgesia
- Registration Number
- NL-OMON22415
- Lead Sponsor
- MC Haaglanden
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Ropivacaine levels in the shed blood collected with Bellovac ABT;<br /><br>2. Ropivacaine levels in the circulating blood of the patient.
- Secondary Outcome Measures
Name Time Method 1. VAS pain scores per hospital protocol;<br /><br>2. Opioid consumption (amount of morphine used with PCA pump) 24, 48 and 72hrs;<br /><br>3. Several important time points will be documented: Start operation, injection of single shot, tourniquet release, leaving recovery and blood samples;<br /><br>4. Muscle power according to MRC.