Trial document




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  DRKS00009378

Trial Description

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Title

Comparison between intraoperative administered wound catheter for continuous local anaesthetic infusion versus oral pain therapy for the treatment of acute and chronic pain after neck dissection because of head and neck cancer - a prospective observational study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Cancer of the head and neck occurs commonly in Germany. In case of neck dissection up to 80 % of the patients develop chronic, mostly neuropathic pain with comcomitant deterioration in quality of life. Those pain symptoms can be difficult to treat. In our projected observational study we will include an overall of 60 patients in 2 consecutive study groups. At first the investigation of the patients without a wound catheter will be carried out (group A, n = 30): These patients receive oral pain medications. After that all following patients (group B, n = 30) will be operated with intraoperative application of a wound catheter for postoperative continuous infusion of ropivacaine.
Primary endpoint of this study is the pain rate with NRS > 0 (Numeric rating scale 0 - 10) 3 months after operation. Secondary endpoints are the consumption of pain medication, adverse side effects, mortality, morbidity and perioperative complications. We expect an improvement in pain therapy for neck dissection and a reduction in therapy caused acute and chronic neuropathic pain due to our study.

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Organizational Data

  •   DRKS00009378
  •   2015/11/19
  •   [---]*
  •   yes
  •   Approved
  •   15-267, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Oral pain medication consisting of a non-opioid (for example metamizole) and if required an opioid (tilidine or oxycodone).
  •   Intraoperative application of a wound catheter. It will be placed below the sternocleidomastoid muscle. The wound catheter secretes continuously ropivacaine 0,2% with a rate of 3 ml/h inside the wound area.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

Rate of pain with an intensity more than NRS 0 (Numeric rating scale, 0 = no pain; 10 = maximum pain) 3 months after operation.

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Secondary Outcome

- Neuropathic pain component: measured with Pain Detect Questionnaire at every postoperative day and 2, 4, 6 and 12 months postoperatively.
- Pain intensity: measured with Numeric Rating Scale (0 - 10) at every postoperative day and 2, 4, 6 and 12 months postoperatively.
- Quality of Life: measured with SF36 questionnaire at every postoperative day and 2, 4, 6 and 12 months postoperatively.
- (Additional) use of pain medication: registration of the amount of administered Non-opioids and Opioids (morphine equivalence dose) at every postoperative day and 2, 4, 6 and 12 months postoperatively.
- Mortality, measured during hospital stay.
- Morbidity: measured during hospital stay.
- Therapy caused adverse side effects: measured at every postoperative day and 2, 4, 6 and 12 months postoperatively.
- perioperative complications, for example dysfunction in wound healing,measured during hospital stay.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients who are planned for an unilateral or a bilateral neck dissection and who are released for the operation after completion of all preoperative examinations.
- Minimum age of 18 years.
- Present written consent after detailed information about the study.
- ASA classification I-III
- 50 – 120 kg body weight

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Exclusion Criteria

- Intolerance against ropivacaine or other local anaesthetics of amide type.
- Preexisting chronic pain.
- Age under 18 years.
- No presence of informed consent for the study.
- No release for the operation after completion of all preoperative examinations.

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Addresses

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    • Schmerzzentrum der Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Johannes  Löser 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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    • Klinik für Hals-Nasen-Ohren-Heilkunde, Uniklinik Köln
    • Mr.  Dr. med.  Antoniu-Oreste  Gostian 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Schmerzzentrum der Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • Mr.  Dr. med.  Johannes  Löser 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Schmerzzentrum, Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • Mr.  Dr. med.  Johannes  Löser 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • Mr.  Prof. Dr. med.  Bernd  Böttiger 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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Trial Publications, Results and other Documents

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