Clinical trial NCT01114984: Post-Breast Procedure Pain Syndrome Study
Official title: A Prospective Cohort Study to Evaluate the Incidence and Characteristics of Post-Operative Pain Among Patients Undergoing Various Breast Surgeries
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast
Mastectomy, Segmental
Keywords: Pain management
Radical mastectomy
Breast surgery
post-operative pain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergo breast surgery. (breast biopsy, lumpectomy, simple mastectomy,mastectomy with reconstruction, radical mastectomy, radical mastectomy with reconstruction, cosmetic augmentation and breast reduction)

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain using VRS
timeFrame: 6 months
Secondary outcomes:
measure: Opioid consumption obtained from the recorded data
timeFrame: 6 months
measure: Postoperative nausea and vomiting using a Verbal Rating Scale
timeFrame: 6 months
measure: Return to normal activities of daily living using follow up questionnaires
timeFrame: 6 months
measure: Patient satisfaction using a verbal rating scale from 0 to 100
timeFrame: 6 months
measure: Hospital stay
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: