Trial document




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  DRKS00005432

Trial Description

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Title

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

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Trial Acronym

PATENT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Comparison of a new pain treatment with tapentadol with conventional pain therapy with morphine in subjects after hysterectomy. The evaluation of therapies is possible as regards their safety and tolerability as well as their impact on the recovery and quality of life after surgery.

Vote of the amendment from BfArM 2015-07-27 nephrectomy and prostatectomy has been removed as possible indications from the study protocol.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00005432
  •   2014/03/14
  •   [---]*
  •   yes
  •   Approved
  •   232/12 A-ff (Mono), Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  •   2012-004585-18 
  •   KKS-190 
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Health Condition or Problem studied

  •   Hysterectomy with ASA 1-3
  •   R52.9 -  Pain, unspecified
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Interventions/Observational Groups

  •   Intervention group hysterectomy with tapentadol Palexia retard 50mg /100mg capsules (Grünenthal Aachen) [oral] and Etoricoxib 60 mg [oral] dosage interval 12h.
    if needed: tapentadol Palexia film-coated tablets 50 mg (not retarded) Grünenthal UK [oral] +
    Morphine sulfate-GRY ®, [iv] (PCA pump).

  •   Control group hysterectomy etoricoxib 60 mg [oral] dosage interval 12h and if needed: morphine sulfate GRY ®, [iv] (PCA pump)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   Yes
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Primary Outcome

cumulative Simplified PONV Impact Scale Score [Wengritzky 2012] over a period of 48 h as
"area under the curve (AUC)".
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".
The simplified ponv is determined: 1 h, 2 h, 4 h, 12 h, 24 h, 36 h und 48 h postoperativ.

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Secondary Outcome

• SDS scores for opioid -associated adverse effects in the dimensions
Severity , frequency, bothersomeness [Apfelbaum 2004]. The SDS scores are collected at the end of a dosing interval , ie usually every 12 hours until the end of the intervention phase.

• HORQ scores for satisfaction and activity level according to the description in [Apfelbaum 2004] HORQ scores are determined every 24 hours from the evening of the first postoperative day until the end of the study.

• Total score of the PPP33 questionnaire [ Eberhart 2004] The questionnaire includes 33 questions for perioperative well-being. The PPP33 questionnaire is completed by the patient on the evening of the first postoperative day.

• Total score of the PPP16 -FT- questionnaire [Eberhart 2008] The questionnaire (re-test version of the questionnaire PPP33) contains 16 questions of the questionnaire PPP33 and can be asked several times in the postoperative period. The PPP16 -FT- questionnaire is used each evening , beginning with the second postoperative day (24 hours after evaluation of the PPP33 -questionnaire) to the end of the intervention period.

• SF -12 questionnaire : It measures the self- perceived health status (12 questions ) . The SF -12 questionnaire is used preoperatively during screening as well as during the last survey date.

• analgesic consumption beyond the retarded Tapentadol medication. At the end of each dosing interval the analgesic consumption is determined and documented, by the amount of morphine delivered via the PCA pump and Palexia filmcoated tablets (not retarded).

• measuring pain (numerical rating scale from 0 to 10 ) 1 , 2, 4 hours after surgery and at the end of each dosing interval subjects are asked assess the degree of pain at rest and during movement. The score always refers to the time interval between the last and the current rated time of measurement.

Additional outcomes:
• Duration of opioid pain therapy
• need for anesthetic drugs (BIS -guided anesthesia with target value : BIS Index : 40-60)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/06/04
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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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. Participation in another clinical trial, that affects the conduct of this study

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Addresses

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    • Philipps-Universität Marburg
    • Mr.  Christoph  Dupuy Backofen 
    • Biegenstraße 10
    • 35032  Marburg
    • Germany
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    • Klinik für Anästhesie und IntensivtherapiePhilipps-Universität Marburg
    • Mr.  Prof. Dr.  Leopold  Eberhart 
    • Baldingerstraße 1
    • 35043  Marburg
    • Germany
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    • Philipps-Universität Marburg
    • Mr.  Prof.  Leopold  Eberhart 
    • Baldingerstraße 1
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Grünenthal GmbH
    • Zieglerstr. 6
    • 52078   Aachen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/02
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.