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临床试验/NCT01114984
NCT01114984撤回不适用

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

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Postoperative Pain using VRS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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
  • 18-80 years of age
  • ASA class I-III adult

排除标准

  • 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

结局指标

主要结局

Postoperative Pain using VRS

时间窗: 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.

次要结局

  • Opioid consumption obtained from the recorded data(6 months)
  • Postoperative nausea and vomiting using a Verbal Rating Scale(6 months)
  • Return to normal activities of daily living using follow up questionnaires(6 months)
  • Patient satisfaction using a verbal rating scale from 0 to 100(6 months)
  • Hospital stay(up to 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

研究点 (1)

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