Post-Breast Procedure Pain Syndrome Study

Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01114984
• Other study ID #: Pro00019341
• Status: Withdrawn
• Phase: N/A
• First received: April 23, 2010
• Last updated: February 26, 2015
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast
• Mastectomy, Segmental

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Hospital stay	Record number of days patients remain in hospital	up to 1 week	No