The effect of morphine and different local anesthetics on human chondrocytes: an in vivo study.

The effect of morphine and different local anesthetics on human chondrocytes: an in vivo study. - LACC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004989-16-BE

Enrollment

100

Registered

2011-11-29

Start date

2012-03-27

Completion date

Unknown

Last updated

2024-12-16

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. MedDRA version: 14.0 Level: LLT Classification code 10024760 Term: Local anesthetic System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Chirocaïne 5,0 mg/ml oplossing voor injectie / concentraat voor oplossing voor perfusie Product Name: Levobupivacaine Pharmaceutical Form: Solution for injection INN or Proposed INN: LEVOB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult = 18 years = 90 years old • Able to comprehend, sign and date the written informed consent document to participate in the clinical trial • Scheduled for total knee arthroplasty • ASA Class I, II or III as assigned by the anesthesiologist 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: • Allergy or inability to tolerate one of the medications used in this study (cfr. 6.2) or other medications used during general anesthesia • Weight less than 50 kilograms • Women with childbearing potential not using contraception • Pregnant and nursing women • Participation in a clinical trial within the past 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate a possible toxic effect of morphine and different local anesthetics on the viability of mature human chondrocytes.;Secondary Objective: ;Primary end point(s): Quantification of the number of death cells;Timepoint(s) of evaluation of this end point: Prelevation of tissue from the lateral condyl of the knee operated on during surgery	—

Secondary

Measure	Time frame
Secondary end point(s): Screening for cell activation/cell damaging/cell death in removed chondrocytes;Timepoint(s) of evaluation of this end point: Prelevation of tissue from the lateral condyl of the knee operated on during surgery	—

Countries

Belgium

Contacts

Public ContactTrial Bureau

Ghent University Hospital

Trialbureau@uzgent.be3293320500

Outcome results

None listed

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