CLINICAL PHARMACOKINETICS OF ROPIVACAINE USING LOCAL INFILTRATION ANESTHESIA (LIA) TECHNIQUE IN THE TOTAL KNEE ARTHROPLASTY: A PILOT STUDY

Completed

• Conditions: Total knee arthroplasty (total knee replacement); 10005944

• Registration Number: NL-OMON37901
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Totaal knee arthroplasty surgery
- Age older than 18 years
- Willing to participate in the study after consultation and written informed consent after Pre-Operative Screening (POS)

Exclusion Criteria

- Known allergy to amide type local anaesthetics or for any other drugs used routinely during this type of surgery
- Mentally retarded
- Taking opiates or antiemetics (other than used in the protocol and used prior to the POS)
- Taking CYP1A2 inhibitors
- Taking CYP3A4 inhibitors
- Liver failure (ALAT, ASAT, gamma-GT and bilirubin > 3 times upper reference value)- Renal failure (GFR <30 ml/min)
- Known alcohol (drink more than 5 alcohol units in any one day), drug or medication abuse. (noted during the POS)
- Renal failure (GFR <30 ml/min, determined with measuring the serum creatin and using the Cockroft-Gault formula)
- Severe obesity (BMI *40)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The determination of pharmacokinetic parameters of ropivacaine after LIA in<br /><br>patients with TKA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>