„Levobupivacaine for postoperative pain control in patients with knee arthroplasty – a comparison with ropivacaine“

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000694-22-DE

Enrollment

Registered

2006-05-05

Start date

2005-11-17

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

patients undergoing total knee arthroplasty

Interventions

Trade Name: Chirocain 1,25mg/ml Infusionslösung Product Name: Levobupivacain Product Code: N01BB10 Pharmaceutical Form: Solution for injection INN or Proposed INN: Levobupivacainhydrochlorid Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients ASA I to ASA III, aged between 18 and 85 years, who gave written informed consent to a regional anesthetic and who are scheduled for total knee arthroplasty Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Insufficiency of heart, liver or kidney; SUD; Gravidity; ASA IV; Allergic disposal to local anesthetics; Patient refuses regional technique

Design outcomes

Primary

Measure	Time frame
Main Objective: It is assumed, that levobupivacaine 0.125% compared to ropivacaine 0.2% provides equal analgesic properties when administered continuously via femoral nerve catheter after total knee arthroplasty, thus resulting in a significant decrease of local anesthetic substance consumption (background infusion + PCA demand). ;Secondary Objective: ;Primary end point(s): Primary endpoint: defined as the cumulative volume of local anesthetic within the first 48 postoperative hours (background infusion + PCA demand).	—

Measure

Time frame

Main Objective: It is assumed, that levobupivacaine 0.125% compared to ropivacaine 0.2% provides equal analgesic properties when administered continuously via femoral nerve catheter after total knee arthroplasty, thus resulting in a significant decrease of local anesthetic substance consumption (background infusion + PCA demand). ;Secondary Objective: ;Primary end point(s): Primary endpoint: defined as the cumulative volume of local anesthetic within the first 48 postoperative hours (background infusion + PCA demand).

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026