Study to describe the processing of ropivacaine in the body when injected in the knee for pain treatment in total knee arthroplasty

Phase 1

Active, not recruiting

• Conditions: patients receiving primary total knee replacement; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-000180-32-NL
• Lead Sponsor: Sint Maartenskliniek Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• 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

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 reason to perform surgery with the use of a tourniquet
-Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified