Trial document




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  DRKS00016517

Trial Description

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Title

Evaluation of the therapeutic success of a standardized analgesic concept in order to treat postoperative pain after surgery of the head and neck in the Department of Otorhinolaryngology - Head & Neck Surgery of the University of Erlangen

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Trial Acronym

EdTsS

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URL of the Trial

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Brief Summary in Lay Language

In this clinical interventional study we want to analyse the effect of a new therapeutic standard for the treatment of postoperative pain in the stationary setting of the Otolaryngology hospital Erlangen. Aim is to improve postoperative pain treatment after surgery of the tonsils and tumours in the head and neck region. Up to now pain treatment is done according to the individual order of the attending physician.
In cooperation with the hospital pharmacy we developed an escalating pain scheme, which is based on the principles of the World Health Organisation. Expected postoperative pain levels are based on German guideline for postoperative pain management.
To evaluate the therapeutic success of the new analgesic concept, adult patients are going to be interviewed with standardized questionnaires on the 1st day after surgery. We want to use the so called QUIPS-questionnaire, where QUIPS stands for “quality improvement in postoperative pain management”.
We want to examine patients after two kind of surgeries in the head and neck region, which are known to correlate with high postoperative pain levels: 1. Removal of the tonsils and 2. Surgery of tumours in the neck area.
We hope to improve postoperative pain therapy by the new therapeutic concept. Long-term goal is to reduce long-term effects of untreated acute pain, for example the development of chronic pain.

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Brief Summary in Scientific Language

In this clinical interventional study we want to analyse the effect of a new therapeutic standard for the treatment of postoperative pain in the stationary setting of the Otolaryngology hospital Erlangen. Our aim is to improve postoperative analgesic treatment after tonsillectomy and pharyngeal tumour resection. Up to now pain treatment is done according to the individual order of the attending physician.
In cooperation with the hospital pharmacy we developed an escalating pain scheme, which is based on the WHO level-scheme. Expected postoperative pain levels are based on German S3 guidelines on treatment of acute perioperative and posttraumatic pain (AWMF guidelines 041/001).
To evaluate the therapeutic success of the new analgesic concept, adult patients are going to be interviewed with validated questionnaires on the 1st postoperative. Therefore we want to use the so called QUIPS-questionnaire, where QUIPS stands for “quality improvement in postoperative pain management”.
We want to examine patients after two kind of surgeries in the head and neck region, which are known to correlate with high postoperative pain levels: 1. Tonsillectomy and 2. Pharyngeal tumour resection.
We hope to improve postoperative analgesic therapy by the new therapeutic concept. Long-term goal is to reduce long-term effects of untreated acute pain, for example the development of chronic pain.

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Organizational Data

  •   DRKS00016517
  •   2019/01/07
  •   [---]*
  •   yes
  •   Approved
  •   224_18 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   J35.0 -  Chronic tonsillitis
  •   C14.0 -  Malignant neoplasm: Pharynx, unspecified
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Interventions/Observational Groups

  •   The control group is planned to exist of 50 patients (25 patients after tonsillectomy and 25 patients after tumour resection). Patients are going to receive analgesic treatment according to the attending physician.
  •   After introduction of the new therapeutic concept, another 50 patients are going to receive analgesic treatment according to the new pain standard.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary efficacy endpoint is defined as the daily average and maximum pain severity (numeric rating scale (NRS): 0 (no pain) - 10 (worst pain imaginable)) on the first postoperative day.
We want to use the so called QUIPS (quality improvement in postoperative pain management)-questionnaire for our data collection before and after introduction of the new analgesic concept. The questionnaire has been validated within a German wide benchmark project (so called QUIPS-project) and allows a comparison with other hospitals as well. Patients have to answer questions covering pain intensity, functional impairment, side effects of the medical condition or analgesic treatment and subjective global assessment. This is complemented by a part filled out by the attending physician covering relevant information about the patient, details about anaesthesia and surgery as well as analgesic score.

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Secondary Outcome

Secondary endpoints comprise analgesic score, treatment-related side effects, pain related functional impairment, peri- and postoperative complications and patient satisfaction.
Data collection is also planned using the QUIPS-questionnaire on the 1st postoperative day.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/01/14
  •   100
  •   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

Inclusion criteria are as follows: patients undergoing bilateral total tonsillectomy or a pharyngeal tumour resection. In addition:
- minimum age of 18 years.
- sufficient cognitive and language skills in order to understand the content of the questionnaire.
- informed written consent after detailed clarification about the study.
- American Society of Anaesthesiologists (ASA) status I-III.
- Body weight of 50-120 kg.

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Exclusion Criteria

Single sided and partial tonsillectomy, tonsillectomy à chaud, tonsillectomy due to oncologic indication, medical history of pre-existing chronic pain, age of under 18 years, prevalence of significant central nervous system disease, obstructive sleep apnoea and/or refusal to participate in the study.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HNO-Klinik Universitätsklinikum Erlangen
    • Mr.  PD Dr. med.  Antoniu-Oreste  Gostian 
    • Waldstraße 1
    • 91054  Erlangen
    • Germany
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    • HNO-Klinik Universitätsklinikum Erlangen
    • Mr.  PD  Antoniu-Oreste  Gostian 
    • Waldstrasse 1
    • 91054  Erlangen
    • Germany
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    • HNO-Klinik Universitätsklinikum Erlangen
    • Mr.  PD Dr. med.  Antoniu-Oreste  Gostian 
    • Waldstraße 1
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • HNO-Klinik Universitätsklinikum Erlangen
    • Mr.  PD Dr. med.  Antoniu-Oreste  Gostian 
    • Waldstraße 1
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting planned
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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.