Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011079

Trial Description

start of 1:1-Block title

Title

Effects of placebo intervention on postoperative pain management in patients following breast cancer operations

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PAF-Study

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The clinical relevance, especially the therapeutic potential of the placebo effect is a growing awareness in recent years in medicine. A crucial psychological mechanism here is the induction of a positive expectation with respect to a drug or otherwise therapy, usually by instructing the patient. The particular clinical relevance of the placebo effect is, in particular, that a targeted induction of positive expectations may enhance the effects of actual pharmacological intervention. A particularly "effective" method of inducing a placebo analgesia is the use of sham acupuncture. The effects of sham acupuncture are solely based on anticipation processes. Based on these findings the objective of the current study is to analyze the effects of a placebo intervention in the context of post-operative pain management, ie in the direct clinical use in acute pain. For this, patients are to be analyzed in the context of postoperative pain in breast cancer patients after breast conserving surgery for the effectiveness of a sham acupuncture.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In pain research, experimental findings for placebo analgesiaare increasingly translated from basic science experiments into clinical application. The induction of a positive expectation with respect to a drug is a major psychological mechanism that is now well understood on the central nervous system level. These mechanisms are analyzed in experimental models of placebo analgesia by imaging techniques in ongoing studies. It is the aim of this study to analyze the effects of a placebo intervention in the context of post-operative pain management.
The aim of the study is to test the following hypotheses:

1. During effective postoperative analgesia using a PCIA pump, morphine dose and the number of PCIA requirements and opioid Distress can be reduced by sham acupuncture.
2. The effect of sham acupuncture on the dependent variables mentioned above can be significantly strengthened by targeted positive expectancy.
3. Pre-operative anxiety, high stress and negative expectations / prior experience are predictors of the placebo effect, that is, the placebo effect is greater in patients with high anxiety and stress scores and lower in patients with negative expectations and / or previous experience.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011079
  •   2016/11/03
  •   [---]*
  •   yes
  •   Approved
  •   12-5155-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Mamma-Carcinoma
  •   C50 -  Malignant neoplasm of breast
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   positive expectation plus sham-acupuncture, patients receive empathic informative talks and have additional sham-acupuncture
  •   neutral expectation with sham-acupuncture, patients receive normal informative talk and additional sham-acupuncture
  •   positive expectation without acupuncture, patients receive empathic informative talk without additional acupuncture
  •   neutral expectation without acupuncture, patients receive normal informative talk without additional acupuncture
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, data analyst
  •   Placebo
  •   Treatment
  •   Factorial
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

postoperative pain medication, 24h postoperatively which is measured by analyzing data from patient controlled intravenous analgesia

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

pain expectation, 24h postop. questionnaire
satisfaction with pain therapy, 24h postop, questionnaire
serum cortisol concentration, 24h postop

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/01/21
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

breast cancer operation

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

chronic pain medication
chronic therapy with cortisol
Ablativ mammae
Porphyria
allergy against opioids
heart failure NYHA III and IV
COPD Gold III and IV
local infection of the ear
kidney disease with creatinine greater 1.5 mg/dl

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/12/14
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.