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

Chronic Pain Clinical Trial

— PREDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767168
• Other study ID #: CER 10-218
• Secondary ID: matped 10-054
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: July 29, 2016
• Start date: May 2011
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Pain, Postoperative

Intervention

Other:
• comprehensive preoperative testing for risk factors of persistent postoperative pain
nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of pain at the site of surgery	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	4 months postop	No
Secondary	acute pain	maximum pain >3/10	24h	No
Secondary	subacute pain	average pain, maximum pain >2	1 week	No
Secondary	prevalence of pain necessitating analgesics at the site of surgery		4 months	No
Secondary	prevalence of pain at the site of surgery		8 months	No
Secondary	prevalence of pain at the site of surgery		12 months	No