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.

Perioperative administration of Tapentadol – tolerance, safety and effects on postoperative rehabilitation and quality of life. Randomized, controlled study to compare the analgesic therapy with tapentadol compared to pure opioid receptor agonists - PATENT - Perioperative Administration of TapENTadol

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004585-18-DE

Enrollment

Unknown

Registered

2012-12-07

Start date

2013-08-27

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy with ASA 1-3, Prostatectomy with ASA 1-3, Nephrectomy with ASA 1-3 MedDRA version: 14.1 Level: PT Classification code 10021151 Term: Hysterectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10029116 Term: Nephrectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10061916 Term: Prostatectomy System Organ Class: 10042613 - Surgical and medical pr

Interventions

Trade Name: Palexia retard Retardtabletten (Wirkstoff: Tapentadol) Product Name: Palexia® retard Retardtabletten Pharmaceutical Form: Prolonged-release tablet CAS Number: 175591-23-8 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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] • HORQ-scores for satisfaction and activity level after description in [Apfelbaum 2004] • Total score of PPP33 questionnaire [Eberhart 2004] • Total score of PPP16 FT-questionnaire [Eberhart 2008] • SF-12 questionnaire • analgesic consumption • measuring pain (numerical rating scale of 0 to 10) Additional outcomes: • Duration of opioid pain therapy • need for anesthetic drugs (for BIS-guided anesthesia with target: BIS Index: 40-60) ;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	—

Measure

Time frame

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] • HORQ-scores for satisfaction and activity level after description in [Apfelbaum 2004] • Total score of PPP33 questionnaire [Eberhart 2004] • Total score of PPP16 FT-questionnaire [Eberhart 2008] • SF-12 questionnaire • analgesic consumption • measuring pain (numerical rating scale of 0 to 10) Additional outcomes: • Duration of opioid pain therapy • need for anesthetic drugs (for BIS-guided anesthesia with target: BIS Index: 40-60) ;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

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Secondary

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

Measure

Time frame

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

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Countries

Germany

Contacts

Public ContactKKS Marburg

Philipps-Universität Marburg

info@kks.uni-marburg.de0049642128 66509

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026