A randomized, open, three-arm comparative study of modern methods of postoperative pain therapy in patients with knee endoprostheses.

Phase 1

• Conditions: Postoperative pain therapy after implantation of a knee endoprosthesis; MedDRA version: 21.1Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-001725-27-DE
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Age: from 18 years
- Indication for implantation of a unilateral knee endoprosthesis
- Patients with (American Society of Anesthesiologists) ASA Score 1 to 3
- Signed informed consent

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- other endoprosthesis on a lower extremity with NRS > 4
- Patients with a previous spinal surgery
- inflammatory bowel diseases
- permanent intake of opioids WHO stage III (more than 6 weeks before the planned surgery)
- clinically relevant Obstructive Sleep Apnea Syndrome
- disorders of bone marrow function (e.g. after cytostatic treatment) or diseases of the haematopoietic system
- genetically determined glucose-6-phosphate dehydrogenase deficiency
- acute intermittent hepatic porphyria
- serious impairment of lung function, clinically relevant COPD, Cor pulmonale
- severe bronchial asthma, severe coagulation disorders or other contraindications to the development of peripheral nerve block
- active peptic ulcers or gastrointestinal (GI) bleeding
- allergies or intolerances to sufentanil and oxycodone
- Allergies or hypersensitivities to amide-type local anesthetics
- Allergies or hypersensitivities to the active ingredients of parecoxib and metamizole
- Decompensated or inadequately treated heart failure (NYHA III to IV), clinically newly proven coronary artery disease within the last 6 months, peripheral arterial occlusive disease and/or cerebrovascular events within the last 6 months
- considerable hypotension and bradycardia as well as severe prostate hyperplasia and biliary tract diseases
- Infection at the injection site for regional anesthesia
- Cirrhosis of the liver Child-Pugh Grade B and C
- GFR < 30
- pregnant or breastfeeding patients
- women capable of giving birth without contraception; all measures with a Pearl index <1 are regarded as reliable contraception, other methods such as natural contraception are regarded as inadequate contraception.
- Refusal of aaspiration by the patient
- Patients unable to consent
- Participation in another drug study
- officially and/or legally accomodated persons

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified