A randomized, multicenter, open-label comparative study comparing a multimodal concept of systemic pain therapy with regional anesthesia in patients undergoing total knee replacement.
- Conditions
- total knee replacement (OPS: 5-822)postoperative pain therapy using peripheral regional anaesthesia (OPS: 8-915)postoperative pain therapy using multimodal approach (OPS: 8-918)
- Registration Number
- DRKS00014185
- Lead Sponsor
- Klinik für Anästhesie und Intensivtherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Unilateral knee endoprothesis
Patients with (American Society of Anesthesiologists) ASA score 1 to 3
- Signed consent
- Patients with ASA score> 3
- Continued use of opioids (more than 6 weeks before the scheduled operation)
- Clinically relevant obstructive sleep apnea syndrome
- Clinically relevant COPD
- pre-existing reduction in vigilance
- respiratory depression, increased intracranial pressure
- Contraindications to the use of Zalviso according to SPC of the system
- severe coagulation disorders or other contraindications to the attachment of a peripheral nerve block
- Allergies or intolerances to sufentanil
- Allergies or hypersensitivity to local anesthetics of the amide type
- Hepatic insufficiency with signs of a synthesis disorder
- Cirrhosis Child-Pugh Grade B and C
- pregnant or nursing patients
- women of childbearing potential without contraception
- Alcohol or drug abuse
- Non-consenting patients
- Participation in another study
- Persons who are in a dependency or employment relationship with the sponsor or examiner
- Imprisoned persons
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjectively perceived quality of life in the perioperative period as measured by the PPP33 questionnaire (48 hours postoperatively)
- Secondary Outcome Measures
Name Time Method