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Completed

NCT Number: NCT01767168

Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery

The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.

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Key information

Conditions

Chronic Pain Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >=18 years
  • American Society of Anesthesiology functional status I-III
  • able to read and understand the information sheet and give informed consent

Exclusion criteria

none

Treatment and study plan

comprehensive preoperative testing for risk factors of persistent postoperative pain

Other

nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences

Primary outcomes

  1. prevalence of pain at the site of surgery

    Time frame: 4 months postop

    clinically important pain defined as either necessitating analgesic treatment or having an intensity of more than 3/10 at rest or 5/10 on movement, at 4 months after surgery

Secondary outcomes

  1. acute pain

    Time frame: 24h

    maximum pain >3/10

  2. subacute pain

    Time frame: 1 week

    average pain, maximum pain >2

  3. prevalence of pain necessitating analgesics at the site of surgery

    Time frame: 4 months

  4. prevalence of pain at the site of surgery

    Time frame: 8 months

  5. prevalence of pain at the site of surgery

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test

Acronym: PREDO

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jan 14, 2013
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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