Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study

Phase 1

• Conditions: Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee; MedDRA version: 19.0Level: LLTClassification code 10031174Term: OsteoarthrosisSystem Organ Class: 100000004859; MedDRA version: 19.0Level: LLTClassification code 10031158Term: Osteo arthritis kneesSystem Organ Class: 100000004859; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-002035-15-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-12
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion: Informed consent, patients of 18-75-years, body mass index not more than 40kg/m2, ASA classification I-III
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Patients with no long term strong opioid use, no contraindications for medications or anaesthesia used

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim is to evaluate the best possible anaesthesia in association to total knee arthroplasty;Secondary Objective: The aims are to find the patients at risk for complications e.g. chronic pain, as well as to find the best protocol for patient flow at the operational unit;Primary end point(s): Primary end point is acute pain (the amount of pain medication used within 24 hours after operation and pain by NRS. ;Timepoint(s) of evaluation of this end point: 24 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end points: vomiting, nausea (NRS 1-10), chronic pain (BPI-SF), chronic pain risk index, knee function (OKS), quality of life (15D), patient satisfaction, complications, lenght of stay at the hospital, times at the operation unit;Timepoint(s) of evaluation of this end point: 24 hours to 12 months