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Pain After Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03307525
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
Society for Ambulatory Anesthesia (SAMBA)
Information provided by (Responsible Party):
Duke University

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

Condition or disease
Breast Cancer Surgery

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain
Actual Study Start Date : June 20, 2012
Actual Primary Completion Date : December 22, 2015
Actual Study Completion Date : December 22, 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Acute Pain [ Time Frame: 72 hours after surgery ]
    Maximum pain score reported postoperatively


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing elective breast cancer surgery
Criteria

Inclusion Criteria:

  • English speaking undergoing elective breast cancer surgery

Exclusion Criteria:

  • Patients with recurrent cancer, metastasis, and previous breast surgery
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03307525    
Other Study ID Numbers: Pro00026402
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No