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

Completed

• Conditions: Acute Pain; Chronic Pain

• Registration Number: NCT01767168
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Primary Completion: 2015-04
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
acute pain	24h	maximum pain \>3/10
prevalence of pain necessitating analgesics at the site of surgery	4 months
subacute pain	1 week	average pain, maximum pain \>2
prevalence of pain at the site of surgery	12 months

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland