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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10% after breast biopsy | Incidence Post-operative pain after breast surgery. | ||
| 20% after lumpectomy | Incidence Post-operative pain after breast surgery | ||
| 30% after simple mastectomy | Incidence Post-operative pain after breast surgery | ||
| 50% after mastectomy with reconstruction | Incidence Post-operative pain after breast surgery | ||
| 50% after radical mastectomy | Incidence Post-operative pain after breast surgery | ||
| 50% after radi mastectomy+reconstruction | Incidence Post-operative pain after breast surgery after radical mastectomy with reconstruction | ||
| 40% after cosmetic augmentation | Incidence Post-operative pain after breast surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergo breast surgery. (breast biopsy, lumpectomy, simple mastectomy,mastectomy with reconstruction, radical mastectomy, radical mastectomy with reconstruction, cosmetic augmentation and breast reduction)
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 40% after breast reduction | Incidence Post-operative pain after breast surgery |
| 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 |
| 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 |
| 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 |
| Hospital stay | Record number of days patients remain in hospital | up to 1 week |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |