Post-Breast Procedure Pain Syndrome Study

A Prospective Cohort Study to Evaluate the Incidence and Characteristics of Post-Operative Pain Among Patients Undergoing Various Breast Surgeries

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast; Mastectomy, Segmental

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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
40% after breast reduction; Incidence Post-operative pain after breast surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 26, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Pain management; Breast surgery; post-operative pain; Radical mastectomy
• Other Study ID Numbers: Pro00019341