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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33633
Enrollment
20
Registered
2009-01-23
Start date
2009-03-27
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 - HB level above 7.5 mmol/L - ASA I-II - both arms can be used for blood collection

Exclusion criteria

Exclusion criteria: - allergic for used medication or othe 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, 3, 6 and 24 h after surgery) and in the blood and 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 pain scores pre, 6hrs, 12hrs and 24hrs * 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)