Acute Pain Trajectories and Persistent Pain After Breast Cancer Surgery

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823015
• Other study ID #: ANES-AS-002
• Status: Completed
• Phase: N/A
• First received: May 30, 2016
• Last updated: June 30, 2016
• Start date: October 2014

Study information

• Verified date: June 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Breast Neoplasms

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Woluwé-St-Lambert

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No		3 months	No
Secondary	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	No