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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01114984
Other study ID # Pro00019341
Secondary ID
Status Withdrawn
Phase N/A
First received April 23, 2010
Last updated February 26, 2015
Start date July 2009
Est. completion date June 2014

Study information

Verified date February 2015
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to better understand and characterize the pain that some patients experience after undergoing various breast surgeries, including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and breast reduction.


Description:

Post-operative breast pain is one of the most common adverse effects after breast surgery procedures. According to previous studies, anywhere from 20-60% of breast surgery patients report mastalgia as an adverse outcome of surgery (1, 2). Although the exact mechanism has not been well defined, the pain is generally neuropathic in nature and described as a burning sensation, electric and shock like, with a stabbing quality (2,3). The large majority of post-operative mastalgia is therefore believed to be secondary to nerve damage, particularly injury to the intercostobrachial nerve, and less commonly the long thoracic, medial and lateral pectoral, and/or the thoracodorsal nerves. Other reported causes of post-operative breast pain include scarring pain, lymphedema, radiation plexopathy, and hematomas (1-5).

Increasing rates of breast surgeries, whether elective, diagnostic, prophylactic, or therapeutic, warrant a more detailed examination of this pain-syndrome, particularly as previous research in the area is rather limited and narrow. A better understanding of the potential mechanisms causing pain, as well as more accurate and current incidence rates, and comparisons of adverse outcomes among the various options available to patients can help guide physicians towards improved clinical practices and patients towards more informed decision-making. Therefore, we designed this prospective cohort study to better understand the underlying mechanisms which may cause post-operative pain after various types of breast surgeries including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic augmentation, and breast reduction, as well as to compare and contrast incidence, quality, and distribution of the post-operative pain caused by these various surgical procedures.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients scheduled to undergo one or more of the breast surgical procedures being studied for this project

- Willingness and ability to sign an informed consent document

- No allergies to anesthetic or analgesic medications

- Female,

- 18-80 years of age

- ASA class I-III adult

Exclusion Criteria:

- Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications

- Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, or history of chronic pain syndrome or neuropathy.

- Subjects with a history of alcohol or drug abuse within the past 3 months

- Subjects with a history of pain medication abuse

- Any other conditions or use of any medication which may interfere with the conduct of the study

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Cedars Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain using VRS prospective cohort evaluation of patients undergoing various breast surgery procedures, followed for a period of 6 months post-operatively, and assessed for post-operative breast pain. 6 months No
Secondary Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 1, 2, or 3, then 7 days and at 6 months after surgery) 6 months No
Secondary Postoperative nausea and vomiting using a Verbal Rating Scale Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 days and 6 months after surgery 6 months No
Secondary Return to normal activities of daily living using follow up questionnaires Questionnaires will help evaluate patients recovery and return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities). Patients will be contacted via mail or e-mail. 6 months No
Secondary Patient satisfaction using a verbal rating scale from 0 to 100 Patients will state their satisfaction level on a scale of 0= Not satisfied to 100= Excellent 6 months No
Secondary Hospital stay Record number of days patients remain in hospital up to 1 week No
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