Post Mastectomy Pain Syndrome at an Indian Tertiary Cancer Centre: Incidence, Pain Severity, Impact on Daily Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of Post mastectomy pain syndrome (PMPS)
研究概览
简要总结
Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers in women. Incidence rises in early thirties, peaks at 50-64 years. Approximately 48% are below 50 years of age. Most present when symptoms develop, so are 2B and beyond. Treatment depends on the stage of the disease. Surgical removal of the tumour is part of the treatment attempting a cure.
Simple mastectomy involves removal of breast tissue without axillary lymph node dissection or removal of chest wall muscles. Radical mastectomy involves removal of the entire breast, skin, pectoralis major and minor muscles and ipsilateral axillary lymph nodes. Modified radical mastectomy involves removal of the breast and ipsilateral axillary lymph nodes. The pectoralis muscle is preserved. Breast conserving surgery involves removal of tumour with or without axillary dissection. The extent of surgery tells us about the nerve damage, local tissue handling. For example operating in upper and outer quadrant of breast and axilla increases nerve handling in that particular region. Local radiation also plays a role.
Persistent pain after mastectomy was first reported in the 1970s by Wood and defined by International Association for Study of Pain (IASP) as pain in the anterior aspect of the thorax, axilla, and/or upper half of the arm beginning after mastectomy or quadrantectomy and persisting for more than three months after surgery and known as Postmastectomy pain Syndrome (PMPS). It is a common problem, with a 25- 60% incidence. The pain is described as burning or tenderness with paroxysms of lancinating, shock-like pain, and also described by some as dysesthesia (perception of non noxious stimuli as painful). Risk factors for PMPS include age, raised Body mass index (BMI), severity of postoperative pain, type of surgery, susceptibility to pain with a history of other pains such as headache and dysmenorrhoea. Axillary hematoma and postoperative radiotherapy have also been implicated in the development of PMPS.
Tata Memorial Hospital, is a tertiary cancer institute in India. Around 4000 patients with suspected breast cancers register annually at the hospital and approximately 2800 breast cancer surgeries are performed yearly. Very few studies on PMPS in Indian population exist. We therefore plan to identify the incidence of PMPS in our patients and also the severity of pain along with its impact on daily function and quality of life
详细描述
Tata Memorial Hospital, a 629 bed tertiary cancer institute conducts approximately 6000 surgeries per year. Approximately 4000 (4239 in 2015) patients with suspected breast cancers register annually at the hospital and around 2800 breast cancer surgeries are performed every year. Very few studies on PMPS in Indian population exist. The investigators therefore, aim to identify the incidence of post mastectomy pain syndrome PMPS) in this population. The investigators also aim to identify the severity of postmastectomy pain along with its impact on daily function and quality of life.
STUDY DESIGN:
Prospective study over 12 months with follow up until 6th month from enrollment with interim analysis in the month of November for presentation of the CoPI's thesis.
MATERIALS & METHODS:
Prospective study over a period of 12 months from commencement of study after Institutional ethics committee approval, at Tata Memorial hospital and ACTREC. Female patients scheduled for undergoing surgery for breast cancer conservative and radical and willing to participate will be enrolled in the study after obtaining a written informed consent. Pain scores will be assessed using Numerical rating scale [with pain score 1-3 mild, 4 to 6 moderate and 7 and above severe]. History of predisposition to recurrent headaches and dysmenorrhea will be noted. Details of disease stage, chemotherapy and/or radiotherapy will also be documented from the Electronic medical records. Analgesia will be managed by the primary surgical team as is currently being done. The analgesia administered to the patient will also be recorded. participants noted to have moderate to severe pain despite analgesics prescribed by the surgical team will be referred to the acute pain service (APS) for further management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Female patient undergoing mastectomy simple radical with or without axilla dissection
- •Literate and can read and write in either English, Hindi, Marathi
- •Willing to fill forms and post them and/or answer questions on phone
排除标准
- •Refusal of consent
- •Patient who has previously undergone major surgery around breast and chest wall
- •Benign breast pathology
- •Patient's with impaired cognitive function
- •Emergency surgery
- •PECs block study (PECTORALIS BLOCK)
结局指标
主要结局
Incidence of Post mastectomy pain syndrome (PMPS)
时间窗: 6 months after surgery
presence of pain around the mastectomy site and ipsilateral arm after the mastectomy
次要结局
- pain severity(At 6 months after surgery)
- Impact on daily function(At 6 months after surgery)
- Impact on quality of life(At 6 months after surgery)
研究者
Dr Aparna Chatterjee
Professor
Tata Memorial Centre