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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01767168

Acronym

PREDO

Enrollment

200

Registered

2013-01-14

Start date

2011-05-31

Completion date

2016-05-31

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Pain

Brief 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.

Interventions

OTHERcomprehensive 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
prevalence of pain at the site of surgery	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

Measure	Time frame	Description
acute pain	24h	maximum pain \>3/10
subacute pain	1 week	average pain, maximum pain \>2
prevalence of pain necessitating analgesics at the site of surgery	4 months	—
prevalence of pain at the site of surgery	8 months	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026