Peripheral opioid receptor blockade and opioid analgesic demand
- Conditions
- PainTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2008-003256-29-DE
- Lead Sponsor
- Charité – Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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