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*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.*

*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.* - LABELLO II; Single shots and ropivacaine levels

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34159
Enrollment
20
Registered
2011-01-05
Start date
2011-03-15
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

joint wear (osteoarthritis) own blood donation (autologous blood transfusion)

Interventions

None listed

Sponsors

Medisch Centrum Haaglanden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - primary TKP - Haemoglobin level above 7.5 mmol/L - both arms can be used for blood collection

Exclusion criteria

Exclusion criteria: - allergic for used medication or other local anaesthetics - major operation within 12 weeks before TKP surgery - high risk patients for insultus epilepticus - dutch language not mastered

Design outcomes

Primary

MeasureTime frame
Ropivacaine will be quantified in patient serum (0, 1, 3, 6, 7 and 18-24 h after surgery) and in the shed blood collected with the Bellovac ABT system at the same time points postoperative.

Secondary

MeasureTime frame
- VAS pain scores measured per protocol - Opioid consumption (amount of morfine used with PCA pump) 24, 48 and 72hrs - Several important time points will be documented; start operation, injection of single shot, tourniquet release, leaving recovery and blood samples

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)