Trial document




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  DRKS00011092

Trial Description

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Title

Comparison of patient-controlled intravenous analgesia with morphine to oral pain medication in pain-treatment after tonsillectomy of adults- a prospective obervational study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The complete surgical removal of the palatine tonsil (tonsillectomy) is one of the most common surgical procedures in Germany. Despite of applied pain-treatment, patients regularly suffer from strong pain after the surgical procedure. This clinical observational-study shall monitor the effect of an adjustment to the pain-treatment-standard after tonsillectomy of adults scientifically and quality ensuring. Altogether 60 patients will be surveyed in two consecutive observation groups. Until the introduction of the new pain-treatment-standard the patients (n=30) will receive oral pain-treatment according to the current standard of the otorhinolaryngology at the Universitätsklinik of Cologne. The second observation group (n=30) will receive a patient-controlled analgesia (PCA). With this electronically- controlled infusion pump a patient can apply a given dosage of morphine, at set intervals, by him- or herself. In case of insufficient pain management, the patient may receive additional non-narcotic-analgesics. Both groups will be compared concerning their differences in stated pain-level, content with their pain-treatment, quality of life, medication use, adverse effects, mortality and complications. The purpose of our study is to optimise the pain-treatment after tonsillectomy via PCA.

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Brief Summary in Scientific Language

The tonsillectomy (TE) is one of the most common surgical procedures in Germany (84.217 Tonsillectomies in 2013, DRG statistic of 2013). Despite of applied pain-treatment, post- surgery pain regularly reaches very high levels (Poller et al. 2011, Guntinas-Lichius et al. 2014, Gerbershagen et al. 2013), which even exceed post-surgery pain of gastrectomies and thoracotomies (Gerbershagen et al. 2013). So far a pain- therapeutic concept, based on scientific evidence, does not exist.
This clinical observational study shall analyse whether the level of post-surgery pain after a planned tonsillectomy can be reduced significantly by applying a PCA early on.
The effect of an adjustment to the pain-treatment-standard after tonsillectomy of adults, will be monitored scientifically and quality ensuring.
Altogether 60 patients will be surveyed in two consecutive observation groups. Until the introduction of the new pain-treatment-standard the patients (n=30) will receive oral pain-treatment according to the current standard of the otorhinolaryngology at the University clinic of Cologne. The second observation group (n=30) will receive a patient-controlled analgesia (PCA) and, if necessary, additional non-narcotic-analgesics.
The PCA will be installed directly after surgery in the post-anaesthesia care unit and will remain from the first to the third day post-surgery.
The primary clinical endpoint of this observational-study is the stated pain-level, obtained via Numeric Rating Scale (NRS) pre-surgery and on the first, second and third day post-surgery.
The secondary clinical endpoints are qualitative and quantitative statements concerning content with the pain-treatment, quality of life, medication use, adverse effects, mortality, morbidity and perioperative complications.
The purpose of our study is to optimise the pain-treatment after tonsillectomy via early and routinely application of PCA and possible additional use of non-narcotic-analgesics as part of a new standard of acute-pain treatment.

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Organizational Data

  •   DRKS00011092
  •   2016/09/28
  •   [---]*
  •   yes
  •   Approved
  •   16-190, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   J35.0 -  Chronic tonsillitis
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Interventions/Observational Groups

  •   oral pain-treatment according to the staged acute-pain pattern, which contains WHO stages I-III
  •   PCA installed directly after surgery in the post-anaesthesia care unit and remaining from the first to the third day post-surgery. Patient can apply a given dosage of morphine, at set intervals and set maximal dosage, by him- or herself.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   IV
  •   No
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Primary Outcome

Pain-level: obtained via Numeric Rating Scale (NRS, 0 = no pain, 10 = maximal pain) pre-surgery (to detect chronic pain) and on every day post-surgery (until the third day post-surgery)

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Secondary Outcome

- Quality of life: obtained via SF36 questionnaire pre-surgery und on the 3rd day post-surgery
- Content with the pain-treatment: obtained via Quips-questionnaire on the 3rd day post-surgery
- (Additional) medication use: amount of given non-narcotic-analgesics und opioids, obtained on the 1st -3rd day post-surgery
- Mortality: obtained on the 1st -3rd day post-surgery
- Morbidity: obtained on the 1st -3rd day post-surgery
- Therapy-induced adverse affects: obtained on the 1st -3rd day post-surgery
- Perioperative complications: obtained on the 1st -3rd day post-surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/10/01
  •   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 have been approved for a tonsillectomy after pre-surgical examination
- Present and signed informed consent
- Patient’s consent, after having been informed in detail on the study
- ASA Classification I-III
- 50 – 120 kg bodyweight

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Exclusion Criteria

- Patients, who haven’t signed informed consent
- Patients, who haven’t been approved for a tonsillectomy after pre-surgical examination, due to pre-existing conditions

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Addresses

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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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    • Klinik für HNO, 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 der 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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    • 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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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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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.