NCT01767168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3.9 years

First QC Date

January 10, 2013

Last Update Submit

July 29, 2016

Conditions

Chronic PainAcute Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • acute pain

    24h

  • subacute pain

    1 week

  • prevalence of pain necessitating analgesics at the site of surgery

    4 months

  • prevalence of pain at the site of surgery

    8 months

  • prevalence of pain at the site of surgery

    12 months

Interventions

comprehensive preoperative testing for risk factors of persistent postoperative painOTHER

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women scheduled for any type of breast cancer surgery in a university hospital breast cancer center

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous blood sample

MeSH Terms

Conditions

Chronic PainAcute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benno Rehberg-Klug, MD

    Dept of Anesthesiology, HUG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
médecin adjoint agrégé

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 14, 2013

Study Start

May 1, 2011

Primary Completion

April 1, 2015

Study Completion

May 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

CH(1)