Post-Breast Procedure Pain Syndrome Study

NCT ID: NCT01114984

Last Updated: 2015-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

Breast; Mastectomy, Segmental

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

10% after breast biopsy

Incidence Post-operative pain after breast surgery.

No interventions assigned to this group

20% after lumpectomy

Incidence Post-operative pain after breast surgery

No interventions assigned to this group

30% after simple mastectomy

Incidence Post-operative pain after breast surgery

No interventions assigned to this group

50% after mastectomy with reconstruction

Incidence Post-operative pain after breast surgery

No interventions assigned to this group

50% after radical mastectomy

Incidence Post-operative pain after breast surgery

No interventions assigned to this group

50% after radi mastectomy+reconstruction

Incidence Post-operative pain after breast surgery after radical mastectomy with reconstruction

No interventions assigned to this group

40% after cosmetic augmentation

Incidence Post-operative pain after breast surgery

No interventions assigned to this group

40% after breast reduction

Incidence Post-operative pain after breast surgery

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roya Yumul, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pro00019341

Identifier Type: -

Identifier Source: org_study_id