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

Pain After Breast Surgery



Sponsors


Source

Duke University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

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

Overall Status

Completed

Start Date

2012-06-20

Completion Date

2015-12-22

Primary Completion Date

2015-12-22

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Acute Pain
72 hours after surgery

Secondary Outcome

Measure

Time Frame

Persistent Pain
More than 6 months after surgery

Number Of Groups

1

Enrollment

141

Conditions


Eligibility

Study Pop

Women undergoing elective breast cancer surgery

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

- English speaking undergoing elective breast cancer surgery

Exclusion Criteria:

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

Gender

Female

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Verification Date

2017-10-01

Lastchanged Date

2017-10-05

Firstreceived Date

2017-10-03

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

October 3, 2017

Study First Submitted Qc

October 5, 2017

Study First Posted

October 11, 2017

Last Update Submitted

October 5, 2017

Last Update Submitted Qc

October 5, 2017

Last Update Posted

October 11, 2017


ClinicalTrials.gov processed this data on October 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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