Pain
Conditions
Interventions
Trade Name: Relistor
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients undergoing knee replacement surgery under total anaesthesia, informed consent to participate in the clinical study, capable to give written informed consent, 18-83 years 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Chronic opioid treatment, Chronic pain with psychiatric/psychosomatic component, Abuse of drugs or alcohol, psychiatric/mental disease, Rheumatoid arthritis with chronic steroid or opioid medication, Chronic pulmonary disease with systemic steroid medication; pulmonary hypertension, Severe heart failure (NYHA>III); peripheral vascular disease, Diabetes mellitus with peripheral polyneuropathy (sensory deficit), ulcers/necrosis/infections, Paralysis, neurological deficits, Gastrointestinal dysfunction/inflammation, ileus, Acute infections, cancer, HIV, hepatitis, Pregnancy; emergency surgery, Intolerance reactions to methylnaltrexone, Participation in other trials, Surgery longer than 3 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To achieve adequate postoperative pain relief in patients after knee replacement surgery, a higher accumulative amount of intravenous morphine is needed after blockade of peripheral opioid receptors by active treatment with methylnaltrexone compared to inactive treatment with placebo. ;Secondary Objective: To test the impact of active vs. inactive treatment on pain scores at rest and movement, signs of withdrawal, effects on vital parameters and adverse events, bowel dysfunction, inflammation, sex specific variations;Primary end point(s): Accumulative amount of intravenous morphine over the first 8 hours after surgery.;Timepoint(s) of evaluation of this end point: First 12 hours hourly and after 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Impact of verum vs. placebo treatment on pain scores at rest and movement, signs of withdrawal, effects on vital signs, adverse Events, bowel dysfunction, inflammation, sex specific variation;Timepoint(s) of evaluation of this end point: First 12 hours hourly and after 24 hours | — |
Countries
Germany
Contacts
Public ContactKlinik für Anästhesiologie
Charité – Universitätsmedizin Berlin
Outcome results
None listed