Pharmacokinetic Profile of Ropivacaïne after Periarticular Local Infiltration Analgesia for Primary Total Knee Arthroplasty

Phase 4

Completed

• Conditions: knee arthrosis; total knee arthroplasty; 10023213

• Registration Number: NL-OMON40725
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-05-06
• Results First Posted: 2016-10-04
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- age 50-80 years
- ASA physical health classification I * II
- Body Mass Index (BMI) < 40
- patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) under unilateral spinal anesthesia with 2 mL hyperbaric bupivacaine 0.5%
- scheduled for fast-track protocol TKA
- haemoglobin (Hb) concentration * 7.5 mMol/L
- written informed consent

Exclusion Criteria

- Placement of a surgical drain
- Contra-indications for spinal anesthesia
- Known hypersensitivity to amide-type local anesthetics
- Hepatic or renal insufficiency
- Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
- Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- Mean total and unbound maximum serum concentration of ropivacaine (Cmax)<br /><br>- Mean time to total and unbound maximum serum concentration of ropivacaine<br /><br>(Tmax)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>