CTRI/2024/08/072404尚未招募2/3 期
To Assess The Effect Of Preoperative Repititive Transcranial Magnetic Stimulation On Post Mastectomy Pain Syndrome: A Randomised Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the reduction in incidence of PMPS using SF-MPQ and EQ-5D-3L questionnaire.
研究概览
简要总结
| B Breast carcinoma is the most common malignancy in the world. Surgical removal is main stay of treatment for early-stage breast. One of the postoperative complications is persistent pain which accounts for incidence up to 68 % in mastectomy patients. Post-mastectomy pain syndrome (PMPS) is a persistent neuropathic pain in the chest, axilla, shoulder, or upper arm for over three months after surgery. Repetitive transcranial magnetic stimulation (rTMS) is non-invasive brain stimulation method which has been developed recently used for the treatment of psychiatric and neurological disorders which has shown to provide significant analgesia in patients of neuropathic pain of various causes. We hypothesise that rTMS will reduce immediate postoperative pain and subsequently reduce the incidence of PMPS in patients undergoing chemotherapy. So we have planned this randomised control trial with the primary objective to assess the effect of rTMS on PMPS in patients undergoing modified radical mastectomy under general anaesthesia and to provide clinical evidence for rTMS therapy in reducing the incidence of PMPS. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 18-70 years,
- •American Society of Anaesthesiologists (ASA) physical status I-III,
- •Scheduled for elective surgery for breast cancer (unilateral surgical procedure with or without axillary lymph node dissection).
排除标准
- •Patient refusal,
- •Contraindications to transcranial magnetic stimulation: iii.
- •Patients who have ferromagnetic or magnetic sensitive metal objects implanted in the head or neck areas in close proximity to the TMS coil magnetic fields.
- •Surgical placement of medical devices (eg, metal plates, clips, electrodes, chips, pumps, stimulators, cochlear implants, pacemakers), as well as past exposure to all metal fragments, tattoos rendered with ferromagnetic-containing ink, permanent piercings, and/or other possible metal sources in the head and neck.
- •Neurological or psychiatric disorders, concurrent major depression,H/o head trauma
- •History of substance abuse,
- •ASA-PS IV or more,
- •History of Head trauma.
结局指标
主要结局
To assess the reduction in incidence of PMPS using SF-MPQ and EQ-5D-3L questionnaire.
时间窗: at 3 months
次要结局
- Secondary outcomes include assessment of postoperative opioid consumption up to 24 hrs and postoperative pain assessment up to 24 hours using Numeric Pain Rating Scale (NRS).(up to 24 hours in post-operative period)
研究者
Dr Yukti Sharma
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
研究点 (1)
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