Standard-armed controlled study to assess the impact of tapentadol administration after hysterectomy, prostatektomy or nephrektomie on quality of life and pain management as well as on safety and tolerability in comparison to a conventional pain therapy with morphine using a historical control group.

Phase 1

• Conditions: MedDRA version: 14.1Level: PTClassification code 10061916Term: ProstatectomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10021151Term: HysterectomySystem Organ Class: 10042613 - Surgical and medical procedures; Hysterectomy with ASA 1-3, Prostatectomy with ASA 1-3, Nephrectomy with ASA 1-3; MedDRA version: 14.1Level: PTClassification code 10029116Term: NephrectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2012-004585-18-DE
• Lead Sponsor: Philipps-Universität Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-07
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Woman who undergo abdominal or laparoscopic assisted hysterectomy, or men who undergo radical prostataectomy, as well as woman or men who undergo nephrectomy
2. elective surgery
3. ASA 1-3
4. at least 18 years old
5.negative pregnancy test (nephrectomy in women of childbearing age)
6. capacity
7. Existence of a written informed consent of the patient
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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. People who are in a dependency / employment with the sponsor or investigator

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Simplified PONV Impact Scale Score [Wengritzky 2012];Secondary Objective: • SDS scores for opioid-associated adverse events in the dimensions severity, frequency, and subjective burden [Apfelbaum 2004]<br>• HORQ-scores for satisfaction and activity level after description in [Apfelbaum 2004] <br>• Total score of PPP33 questionnaire [Eberhart 2004]<br>• Total score of PPP16 FT-questionnaire [Eberhart 2008]<br>• SF-12 questionnaire<br>• analgesic consumption<br>• measuring pain (numerical rating scale of 0 to 10)<br>Additional outcomes:<br>• Duration of opioid pain therapy<br>• need for anesthetic drugs (for BIS-guided anesthesia with target: BIS Index: 40-60)<br>;Primary end point(s): cumulative Simplified PONV Impact Scale Score [Wengritzky 2012] as area under the curve (AUC)”;Timepoint(s) of evaluation of this end point: 1 h, 2 h, 4 h, 12 h, 24 h, 36 h und 48 h postoperative<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • SDS scores for opioid-associated adverse events in the dimensions severity, frequency, and subjective burden [Apfelbaum 2004]<br>• HORQ-scores for satisfaction and activity level according description in [Apfelbaum 2004] <br>• Total score of PPP33 questionnaire [Eberhart 2004]<br>• Total score of PPP16 FT-questionnaire [Eberhart 2008]<br>• SF-12 questionnaire<br>• analgesic consumption<br>• measuring pain (numerical rating scale of 0 to 10)<br>Additional outcomes:<br>• Duration of opioid pain therapy<br>• need for anesthetic drugs (for BIS-guided anesthesia with target: BIS Index: 40-60);Timepoint(s) of evaluation of this end point: 0-28 days in advance of operation<br>V1: in advance of anesthesia<br>V2: 1 hour after operation/extubation<br>V3: after 2 hours<br>V4: after 4 hours<br>V5: after 12 hours<br>V6: after 24 hours<br>V7: after 36 hours<br>V8: after 48 hours<br>V9: after 60 hours<br>V10,... : daily until resolution of pain/release<br>last visit: 12 hours after resolution<br>