patienst requiring total knee replacement for non-inflammatory osteoarthritis of the knee
Conditions
Interventions
Trade Name: ropivacaine HCl
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ropivacaine
CAS Number: 132112-35-7
Current Sponsor code: non
Other descriptive name: ROPIVACAINE HYDROCHLO
Sponsors
St. Lucas Andreas Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years and older who are scheduled for a TKA with spinal anesthesia. - age above 18 years - mentally competent - eligible for TKA - 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: -contra indication for spinal anesthesia (severe aortic stenosis, severely compromised cardiac function) - infection at interspace of spinal injection - allergy to used medicine - repeat TKA - all previous surgeries concerning arthrotomy - participation in other research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identifying the optimal analgesia technique for patients undergoing a total knee replacement giving the best functional outcome.;Secondary Objective: - NRS pain score in rest from the day of surgery until day 3 post surgery - NRS pain score in flexion exercise from the day of surgery until day 3 post surgery - NRS pain score postoperatively when walking - range of motion with flexion and extension during 3 postoperative days - length of stay in hospital - side-effects;Primary end point(s): -Opioid consumption measured by mg of morphine i.v. used daily (every morning at 10.00 am) -Mobilization measured by Modified Iowa Levels of Assistance Scale (MILAS);Timepoint(s) of evaluation of this end point: day of surgery, postoperative during hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - NRS pain score in rest from the day of surgery until day 3 post surgery - NRS pain score in flexion exercise from the day of surgery until day 3 post surgery - NRS pain score postoperatively when walking - range of motion with flexion and extension during 3 postoperative days - length of stay in hospital - side-effects;Timepoint(s) of evaluation of this end point: day of operation, postoperative during hospital stay | — |
Countries
Netherlands
Contacts
Public ContactAnesthesiology
St. Lucas Andreas Hospital
Outcome results
None listed