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Postoperative pain relief for primary total knee arthroplasty: A randomised clinical trial of local infiltration anaesthesia followed by intraaticulary infusion compared to epidural infusion - Intraarticulary infiltration and infusion

Postoperative pain relief for primary total knee arthroplasty: A randomised clinical trial of local infiltration anaesthesia followed by intraaticulary infusion compared to epidural infusion - Intraarticulary infiltration and infusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004638-33-DK
Enrollment
80
Registered
2006-10-11
Start date
2006-11-21
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Patients with Osteoarthrosis undergoing elective total knee arthroplasty (TKA)

Interventions

Trade Name: Naropin Product Name: Naropin Pharmaceutical Form: Solution for infusion INN or Proposed INN: ROPIVACAINE CAS Number: 84057954 Concentration unit: mg/ml milligram(s)/millilitre Concentrati

Sponsors

Department of Orthopedic Surgery, Aarhus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age>18 years Primary total knee arthroplasty Written 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known allergi or intolerance to one of the study drugs Pregnat women Pathological obesity (BMI>35) Regular Narcotic use. Patients in treatment for; Depression, epilepsy, diabetes, antacida. Patient with Rheumatoid arthritis. Contraindikations to spinal or epidural anaesthesia Patient wich can not read and understand danish

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine wether local infiltrationanaestesia with Naropin added Toradol and Adrenaline combind with intraarticulary infusion of Naropin and Toradol after total knee arthroplasty can enchange analgesia compared with epidural infusion of Naropin and intravenous infusion of Toradol.;Secondary Objective: To investigate: the occurrence of local and systemic adverse events. Length of stay the occurrence of postoperative Complications. The inflammatoriske respons after TKA Mobilisation level;Primary end point(s): Pain assement: Visuel analog Scale (VAS) (0-72 h postoperatively) Morphine consumption (0-24-48 hours postoperatively)—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026