Postoperative pain therapy after implantation of a knee endoprosthesis MedDRA version: 21.1 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Zalviso 15 Mikrogramm Sublingualtabletten
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: SUFENTANIL CITRATE
CAS Number: 60561-17-3
Concentration unit: µg microgram(s)
Concentr
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to examine the influence of three established postoperative pain therapy procedures on postoperative pain intensity after the implantation of a knee endoprosthesis. The postoperative pain is measured on the 3rd postoperative day at rest and under strain.;Secondary Objective: The secondary objectives are to investigate the influence of the three interventions on patient satisfaction, mobilization, pain chronification and requierement of analgesics. Furthermore, the quality of life, the inflammation parameters and the duration of the inpatient hospitalization will be investigated.;Primary end point(s): Postoperative pain on the 3rd postoperative day at rest and under strain. The pain intensity will be assessed by the patient on the basis of a verbal numerical rating scale (NRS) from 0 (no pain) to 10 (maximum imaginable pain).;Timepoint(s) of evaluation of this end point: 3rd postoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Postoperative pain (NRS) on the 1st and 2nd postoperative day - Patient contentment is determined on the basis of a questionnaire with eight questions about the general contentment with the pain therapy and the treatment team. - Mobilisation determined on the basis of the Forgotten Joint Score (FJS) and the Knee Society Rating. The FJS is determined by means of a questionnaire and checks the patient's perception of the endoprothesis in daily life. The Knee Society Clinical Rating System is an internationally recognized evaluation system with the aim of recording the knee joint's qualitatively and quantitatively measurable characteristics on the one hand and to address the functional aspects in the patient's daily life on the other. The first part of the evaluation system is the knee score, in which a maximum of 100 points can be achieved. It measures the criteria pain, range of motion and stability of the knee. The second part is the Function Score, which evaluates the walking distance and the patients' behaviour when climbing stairs. - Quality of life determined on the basis of the SF 12 questionnaire. - Possible systemic inflammatory reactions investigated by determining the inflammatory parameters BB, CRP, PCT, IL-6. - For the purpose of pain chronification, the pain intensity will be recorded by means of NRS and the analgesic requirement (additional analgesics, parallel or after completion of the treatment phase in hospital). Proportion of patients beeing discharged from hospital with continued pain therapy (recording of opioids separately from non-opioid analgesics) or who still require analgesics at the time of the follow up questioning. - Obstipation (stool frequency of <3×/week) and night sleep (by means of a 3-part rating scale; good night sleep, moderate night sleep, bad night sleep by means of a patient diary) - Safety of the three intervention schemes through the systematic recording of all adverse events.;Timepoint(s) of evalu | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
Universitätsklinikum Halle
Outcome results
None listed