Pain After Breast Surgery

October 24, 2023 updated by: Duke University

A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain

This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women undergoing elective breast cancer surgery

Description

Inclusion Criteria:

  • English speaking undergoing elective breast cancer surgery

Exclusion Criteria:

  • Patients with recurrent cancer, metastasis, and previous breast surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Pain
Time Frame: 72 hours after surgery
Maximum pain score reported postoperatively
72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent Pain
Time Frame: More than 6 months after surgery
pain score ≥ 3 or pain that impacts daily life as indicated by a score >0 on any of the 7 daily activity questions more than 6 months after surgery
More than 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Society for Ambulatory Anesthesia (SAMBA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2012

Primary Completion (Actual)

December 22, 2015

Study Completion (Actual)

December 22, 2015

Study Registration Dates

First Submitted

October 3, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00026402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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