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LABELLO II: Single shots and ropivacaine levels.

- candidate number8841
- NTR NumberNTR2677
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-dec-2010
- Secondary IDs10-093 METC ZuidWest Holland
- Public TitleLABELLO II: Single shots and ropivacaine levels.
- Scientific TitleLocal 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.
- hypothesisIs there some course detectable in the ropivacaine levels in the collected shed blood in patients treated with three single local analgesia shots with ropivacaine after total knee replacement.
- Healt Condition(s) or Problem(s) studiedTotal knee replacement (TKR), Osteoarthritis, Local analgesia
- Inclusion criteria1. 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 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jun-2011
- Target number of participants20
- InterventionsPatients 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 concentrations.
- Primary outcome1. Ropivacaine levels in the shed blood collected with Bellovac ABT;
2. Ropivacaine levels in the circulating blood of the patient.
- Secondary outcome1. 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.
- Timepoints1. 0 (direct postoperative, 1 hour after first single shot);
2. 1 hour after surgery;
3. 3 hours after surgery;
4. 6 hours after surgery;
5. 7 hours after surgery;
6. 18-24 hours (first po morning) after surgery.
- Trial web
- statusstopped: trial finished
- Sponsor/Initiator Medical Center Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
MC Haaglanden
- PublicationsN/A
- Brief summaryEvidence suggests that local infiltration analgesia (LIA) 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). Bellovac ABT (an autologous retransfusion system) is also often used in TKR. Bellovac ABT is used as an alternative to allogeneic blood transfusions. A combination of both techniques however, is not common yet. Before routinely combining LIA with an autologous retransfusion system we want to know the course and levels ropivacaine in the shed blood collected with the Bellovac ABT system. The primary objective is to find a course in the ropivacaine concentrations in shed blood. Patients aged between 18-90 years scheduled for primary total knee replacement with Hb levels above 7.5 mmol/L are eligible for inclusion in the study. Patients will be included according to GCP. After inclusion, patients will be operated and during surgery three single shots with ropivacaine and adrenaline will be administered intra-articular. After surgery, patients receive standard Bellovac ABT (wound) drain in the knee joint. The shed blood collected with the Bellovac ABT system and patients plasma will be analysis at 0, 1, 3, 6, 7 and 18-24 hours (first po morning) after surgery. The shed blood collected will not be retransfused to the patient. The intervention is the intraoperative administration of local infiltration analgesia with three single shots of ropivacaine combined with adrenaline in TKR. The main study parameters/endpoints are the total and unbound ropivacaine will be quantified in shed blood and in patients plasma at 6 time points postoperative.
- Main changes (audit trail)
- RECORD30-dec-2010 - 30-jun-2012

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