Post-Breast Procedure Pain Syndrome Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01114984
First received: April 23, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition
Breast
Mastectomy, Segmental

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Cohort Study to Evaluate the Incidence and Characteristics of Post-Operative Pain Among Patients Undergoing Various Breast Surgeries

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Postoperative Pain using VRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Opioid consumption obtained from the recorded data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients will state their satisfaction level on a scale of 0= Not satisfied to 100= Excellent

  • Hospital stay [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
    Record number of days patients remain in hospital


Estimated Enrollment: 336
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114984

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01114984     History of Changes
Other Study ID Numbers: Pro00019341
Study First Received: April 23, 2010
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Pain management
Radical mastectomy
Breast surgery
post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014