Painfull knee condition of traumatic or other origin, where arthroscopic surgery is indicated, as judged by the surgeon.
Conditions
Interventions
Product Name: Morfin Special 10mg/ml
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intraarticular use
Product Name: Toradol 30
Sponsors
Karolinska Institute, CLINTEC, div of orthopedics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Patients with knee disorder such as suspected meniscus injury, ligament injury, where there is an indication for arthroscopic knee surgery and the planned time for surgery is 20-60mins. b) Age 18-80 years. c) Signed written informed consent, to data handling and to the Personal Data Act of 1998 (PUL). d) ASA class I-II. 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: a) Participation in another clinical trial within 30 days prior to study inclkusion and throughout the study, b) Other severe pain condition complicating pain assessments in the study, as judged by the investigator. c) Progressive malignant disease. d) Systemic inflammatory disease of clinical relevance, as judged by the investigator. e) Other conditions that reduces the ability to participate properly, such as abuse, communicaiton difficulties, as judged by the investigator. f) Allergy or other contraindication for any of the study drugs or paracetamol, such as cardiac failure, hypertension, renal failure or liver failure, coagulopathy. g) intake of nonsteroidal or coxib 72 prior to surgery. h) Known allergy or other contraindication to routine anesthetics, i.e. propofol, soy bean. i) Other concomitant pharmacological or non-pharmacological antiinflammatory treatment, temporarily or regularly,, during the course of the study. j) Pregnancy and/ or lacation. k) Surgery using tourniquet. l) Arthroscopic surgery where free mobilisation will not be allowed postoperatively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of postoperative pain, reduction in postoperative inflammatory response to surgical trauma.;Secondary Objective: Reduced duration of postoperative pain. Shortened rehabilitation period post surgery.;Primary end point(s): Significant relevant reduction in postoperative pain, NRS 0-10, by at least 20%, during the first 8, 24 and 36h post surgery. Attenuation of metabolic response (glucose, lactate and glutamate) postoperatively, as assessed by microdialysate from the synovial membrane, analysed with CMA Analyzer. Attenuation of inflammatory response as assessed by reduced levels of chemokines and of Prostaglandin E2 in microdialysate from the synovial membrane. | — |
Countries
Sweden
Outcome results
None listed