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)
Conditions
Interventions
Group 1: In patients undergoing total knee replacement, analgesia is performed for 72 hours using multimodal systemic analgesia (MSA):
Elements of the MSA are:
- SSTS (sublingual sufentanil-based ther
Sponsors
Klinik für Anästhesie und Intensivtherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Unilateral knee endoprothesis Patients with (American Society of Anesthesiologists) ASA score 1 to 3 - Signed consent
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjectively perceived quality of life in the perioperative period as measured by the PPP33 questionnaire (48 hours postoperatively) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective criteria (confirmatory testing): - Subjective patient assessment of the postoperative period at 24h and 72h after surgery - Postoperative pain at rest and under stress (sum of all 8 NRS rating scales of the postoperative period) - Mobilizability (CAS test) - cumulative time spent by the patient outside the bed after surgery (patient diary) - Stability and gait safety (Tinetti test) - Ease of care questionnaire for nursing staff or physiotherapists - Patient assessment of the analgesia procedure or patient satisfaction (Harding questionnaire and question for recommending the Analgesieverfahrens to friends and relatives) - Assessment of the preoperative phase in the OP (ISAS questionnaire) Secondary objective criteria (descriptive analysis): - Quality of life (SF36) - Disease-specific quality of life (Oxford knee score) - Co-medication in the hospital - Analgesic medication at hospital discharge or after 6 weeks - Side effects (SAE and AE) - Success of rehabilitation measures | — |
Countries
Germany
Contacts
Public ContactLeopold Eberhart
Klinik für Anästhesie & IntensivtherapiePhilipps-Universität Marburg
Outcome results
None listed