Comparison of nerveblock and local infiltration block in the knee after total knee replacement.

• Conditions: patienst requiring total knee replacement for non-inflammatory osteoarthritis of the knee; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-005596-90-NL
• Lead Sponsor: St. Lucas Andreas Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

-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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br> - NRS pain score in flexion exercise from the day of surgery until day 3 post surgery<br> - NRS pain score postoperatively when walking<br> - range of motion with flexion and extension during 3 postoperative days<br> - length of stay in hospital<br> - side-effects;Primary end point(s): -Opioid consumption measured by mg of morphine i.v. used daily (every morning at 10.00 am)<br> -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 Outcome Measures

Name	Time	Method
Secondary end point(s): - NRS pain score in rest from the day of surgery until day 3 post surgery<br> - NRS pain score in flexion exercise from the day of surgery until day 3 post surgery<br> - NRS pain score postoperatively when walking<br> - range of motion with flexion and extension during 3 postoperative days<br> - length of stay in hospital<br> - side-effects;Timepoint(s) of evaluation of this end point: day of operation, postoperative during hospital stay