Perioperative administration of Tapentadol – tolerance, safety and effectson postoperative recovery and quality of life.(PATENT)Randomized, controlled study to compare the analgesic therapy withtapentadol compared to pure opioid receptor agonists
- Conditions
- Hysterectomy with ASA 1-3R52.9Pain, unspecified
- Registration Number
- DRKS00005432
- Lead Sponsor
- Philipps-Universität Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 121
1. Woman who undergo abdominal or laparoscopic assisted
hysterectomy
2. elective surgery
3. ASA 1-3
4. not less than 18 jears old
5. capacity
6. Existence of a written informed consent of the subjects
1. Participation in other interventional trials,
2. Contraindications according to prescribing information
- paralytic ileus
- anamnese to a serotonery syndrom
- acute intoxication with alcohol, centrally acting analgesics or psychotropic substances
3. systemic opioid maintenance therapy within the last 4 weeks
4. Clinically significant hepatic and / or renal failure
5. Intolerance to one of the other drugs used in the study (Propofol, Fentanyl, Remifentanil, Morphine, Rocuronium, Etoricoxib)
6. cognitive disability or language barriers that impede adequate communication with the patient
7. Participation in another clinical trial, that affects the conduct of this study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cumulative Simplified PONV Impact Scale Score [Wengritzky 2012] over a period of 48 h as<br>area under the curve (AUC).<br>The primary objective is to assess the pain therapy with tapentadol in terms of the impact on postoperative nausea and vomiting (PONV), using the validated Simplified PONV Impact Scale.<br>The simplified ponv is determined: 1 h, 2 h, 4 h, 12 h, 24 h, 36 h und 48 h postoperativ.
- Secondary Outcome Measures
Name Time Method