DRKS00014185RecruitingPhase 4
A randomized, multicenter, open-label comparative study comparing a multimodal concept of systemic pain therapy with regional anesthesia in patients undergoing total knee replacement.
Klinik für Anästhesie und Intensivtherapie0 sites180 target enrollmentStarted: March 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •Unilateral knee endoprothesis
- •Patients with (American Society of Anesthesiologists) ASA score 1 to 3
- •- Signed consent
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
Investigators
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