Post-Breast Procedure Pain Syndrome Study

Withdrawn

• Conditions: Mastectomy, Segmental; Breast

• Registration Number: NCT01114984
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Pain using VRS	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption obtained from the recorded data	6 months	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)
Postoperative nausea and vomiting using a Verbal Rating Scale	6 months	Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 days and 6 months after surgery
Return to normal activities of daily living using follow up questionnaires	6 months	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.
Patient satisfaction using a verbal rating scale from 0 to 100	6 months	Patients will state their satisfaction level on a scale of 0= Not satisfied to 100= Excellent
Hospital stay	up to 1 week	Record number of days patients remain in hospital

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States