Acute Pain Trajectories and Persistent Pain After Breast Cancer Surgery

Acute Pain Trajectories as a Predictive Factor for Persistent Pain After Breast Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Belgium
  • Woluwé-St-Lambert, Belgium, 1200
    • Cliniques universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Adult females, scheduled for breast cancer surgery

Description

Inclusion Criteria:

• Scheduled for breast cancer surgery
• General anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute pain trajectories (7 days) after surgery	The pain trajectory is the vector of 7 verbal numerical pain scores (from 0 to 10) recorded in a pain diary over the first 7 postoperative days	One postoperative week

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Arnaud Steyaert, MD, Cliniques universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Acute Pain
• Other Study ID Numbers: ANES-AS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED