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

Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002035-15-FI

Enrollment

400

Registered

2016-05-12

Start date

2016-05-20

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 19.0 Level: LLT Classification code 10031174 Term: Osteoarthrosis System Organ Class: 100000004859 MedDRA version: 19.0 Level: LLT Classification code 10031158 Term: Osteo arthritis knees System Organ Class: 100000004859

Interventions

Trade Name: Bicain spinal Pharmaceutical Form: Solution for injection INN or Proposed INN: bupivacaine hydrochloride Other descriptive name: BUPIVACAINE HYDROCHLORIDE Trade Name: Propolipid Pharmaceu

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Finland

Contacts

Public ContactUniversity Clinic

Helsinki University Central Hospital/ Peijas Hospital

+35894711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026