NCT02823015

Brief Summary

Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. Our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

July 6, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

May 30, 2016

Last Update Submit

June 30, 2016

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No

    3 months

Secondary Outcomes (1)

  • Acute pain trajectories (7 days) after surgery

    One postoperative week

Study Arms (1)

Study population

The study population consists of adult surgery patients, scheduled for breast cancer surgery at St-Luc University Hospital.

Eligibility Criteria

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

Adult females, scheduled for breast cancer surgery

You may qualify if:

  • Scheduled for breast cancer surgery
  • General anesthesia

You may not qualify if:

  • Previous breast surgery
  • Reconstructive surgery scheduled during follow-up
  • Day-surgery patients
  • Inability to understand the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Woluwé-St-Lambert, 1200, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Arnaud Steyaert, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

July 6, 2016

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Last Updated

July 6, 2016

Record last verified: 2016-06

Locations

BE(1)