Pain after total knee arthroplasty MedDRA version: 9.1 Level: LLT Classification code 10003398 Term: Arthroplasty of knee MedDRA version: 9.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief MedDRA version: 9.1 Level: LLT Classification code 10024758 Term: Local anaesthesia MedDRA version: 9.1 Level: LLT Classification code 10041536 Term: Spinal anaesthesia
Conditions
Interventions
Trade Name: Chirocaine
Product Name: Levobupivacaine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLORIDE
CAS Number: 27262482
Concentration unit: µmol micromo
Sponsors
Ninewells Hospital and Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 1.5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this study is to measure the molar ED50 of levobupivacaine and the molar ED50 of ropivacaine when administered as a femoral perineural infusion to prevent pain 30 hours after total knee replacement;Secondary Objective: To assess the: • Degree of postoperative pain • Degree of postoperative pain relief • Need for rescue analgesia • To assess the efficacy and side effects of patients deemed “anaesthetic failures” • Side effect profile of both groups • Functional outcomes such as time to first drinking, mobilization and micturition • Time to readiness for discharge and length of hospital stay • Self-efficacy • Expectancy • Quality of life / health economics using EQ-5D • Mood using the Hospital Anxiety Depression Scale ;Primary end point(s): The primary measure of outcome is the 4-point VRS (pain) at 30 hours. | — |
Countries
United Kingdom
Outcome results
None listed