A randomised single blind study comparing the molar ED50 of levobupivacaine and molar ED50 of ropivacaine when administered as a femoral perineural infusion for pain relief after total knee replacement

Active, not recruiting

• Conditions: Pain after total knee arthroplasty; MedDRA version: 9.1Level: LLTClassification code 10003398Term: Arthroplasty of knee; MedDRA version: 9.1Level: LLTClassification code 10036236Term: Postoperative pain relief; MedDRA version: 9.1Level: LLTClassification code 10024758Term: Local anaesthesia; MedDRA version: 9.1Level: LLTClassification code 10041536Term: Spinal anaesthesia

• Registration Number: EUCTR2008-002136-15-GB
• Lead Sponsor: inewells Hospital and Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

All patients >18 years of age and non pregnant, presenting for elective knee replacement will be approached for recruitment to this study.

Patients expressing an interest in participation will be given an information sheet and a written consent form in the anaesthetic pre-assessment clinic. Patients will be given at least one week to make a decision about study involvement. Once admitted patients will be approached for written consent and entry into the study.
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

•Known hypersensitivity to local anaesthetics or clonidine
•Signs of cardiac failure (3rd heart sound, lung crepitations)
•Type I and type II diabetes
•Abnormal cardiac arrhythmias
•Hypovolaemia
•Presence of seizures,
•Dementia,
•Depression
•Encephalopathy,
•Terminal illness with a life expectancy < 3 months
•Age < 18 years
•Pregnant
•Coagulopathy INR>1.5

Study & Design

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