Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
研究概览
简要总结
Intercostobrachial nerve (ICBN) is a cutaneous nerve that provides sensation to the lateral chest, upper medial arm and axilla. It arises from the second intercostal nerve and leave intercostal space at the level of midaxillary line. It then pierces the serratus anterior muscle and enters axilla. Intercostobrachial nerve is encountered during axillary lymph node dissection (ALND) while mobilizing axillary contents laterally off the chest wall and tends to tether axillary contents to the lateral chest wall. Many surgeons routinely sacrifice it as doing so makes mobilization easier and allow exposure of long thoracic neve. Currently there is no consensus on the usefulness of preserving intercostobrachial nerve.
According to a 2020 systemic review and meta-analysis, prevalence of CPSP/ PPSP following breast cancer surgery ranged from 2% to 78% and pooled prevalence was found to be 35%. Higher prevalence was associated with ALND. Several risk factors have been identified which contribute to the development of PPSP. These include; Preexisting pain, preoperative opioid exposure, genetics, psychological factors such as anxiety, depression or catastrophizing, intensity of acute postoperative pain and nerve injury during surgery.
As a result of nerve injury, damaged and non-damaged nerve fibers start generating action potential spontaneously. These are considered ectopic inputs as they do not arise from peripheral terminals. These inputs lead to the development of central sensitization, which is a state of exaggerated functional response of neurons involved in the pain pathway. This increased sensitization results due to increased membrane excitability, enhanced synaptic efficacy and decreased inhibition.
The aim of the present trial is to investigate the effect of ICBN preservation on chronic/ persistent post surgical pain (CPSP/ PPSP). This will be achieved through a randomized control trial with CPSP/ PPSP as a primary outcome measure. Secondary outcome measures will include Health Related Quality of Life (HRQoL), operating time, lymph node yield, functional status of ipsilateral shoulder, post-operative complications and post-operative use of opioid analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above.
- •Known cases of invasive breast Cancer.
- •Undergoing Axillary Lymph Node Dissection (ALND) alone, ALND with mastectomy or ALND with breast conservation surgery (BCS)
- •Capacity to give informed consent
排除标准
- •Chronic diseases limiting motion of shoulder such as neuropathies, history of trauma and autoimmune diseases.
- •Patients undergoing redo axillary lymph node dissection.
- •Patients undergoing bilateral axillary lymph node dissection.
- •History of chronic pain lasting more than 3 months. Potential causes include: arthritis, backache, fibromyalgia, Irritable bowel disease, irritable bowel syndrome and different types of headache.
- •M1 stage of the TNM staging system at the time of initial diagnosis.
结局指标
主要结局
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
时间窗: 6 Months (Post-Operatively)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows: Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
次要结局
- Operating Time (Minutes)(Intraoperative)
- Lymph Node Yield(Intraoperative)
- Post-Operative usage of Opioid Analgesics(2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively))
- Functional Status of Ipsilateral Shoulder using Shoulder Pain and Disability Index (SPADI) Questionnaire(Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively))
- Post-Operative Complications as per Clavien Dindo Classification (CDC)(From the time of intervention to 30 days (Post-Operatively))
- Health Related Quality of Life using Functional Assessment of cancer therapy-Breast form (FACT-B)(Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively))
- Adverse Events(From the time of intervention to 6 months (Post-Operatively))
研究者
Dr. Ibtissam Bin Khalid
Principal Investigator
Shaukat Khanum Memorial Cancer Hospital & Research Centre