Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Persistent pain at 4 months after surgery
研究概览
简要总结
Pre-existing pain and severe postoperative pain are predictors of persistent pain after surgery, but a complete understanding on the development of persistent pain is still lacking. The study aims to identify clinically relevant and genetic risk factors for persistent postsurgical pain that can be reliably distinguished statistically.
详细描述
The study will focus on: (i) risk factors representing biopsychosocial processes that influence chronic pain, such as pain and psychological vulnerability; (ii) genetic factors relating to mechanistic pathways to persistent pain generation. Patients will be recruited from those undergoing breast cancer surgery at the mentioned site. Pain and anxiety assessment will be conducted via visual analogue scoring, mechanical temporal summation assessment and a series of questionnaires. After the surgery, all patients will be given appropriate analgesia, and the pain score and analgesia usage will be recorded. Phone survey will be conducted 4 and 6 months, respectively, after surgery to determine the outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 21 - 80 year old;
- •Healthy and/or have systemic medical conditions as reviewed by anaesthetist for surgery (ASA 1-3);
- •Undergoing breast cancer surgery.
排除标准
- •History of intravenous drug or opioid abuse;
- •Current chronic daily treatment with corticosteroids (excluding inhaled steroids);
- •Previous history of chronic pain syndrome;
- •Obstetric patients.
研究组 & 干预措施
Persistent post surgical pain (PPSP)
Questionnaires, Mechanical Temporal Summation assessment and pain threshold assessment will be assigned to patient. Within this cohort, some patients will have high pain score recorded (persistent pain) during the follow-up evaluations at 4 and 6 months.
干预措施: Questionnaires (Other)
Persistent post surgical pain (PPSP)
Questionnaires, Mechanical Temporal Summation assessment and pain threshold assessment will be assigned to patient. Within this cohort, some patients will have high pain score recorded (persistent pain) during the follow-up evaluations at 4 and 6 months.
干预措施: Mechanical Temporal Summation assessment (Other)
Persistent post surgical pain (PPSP)
Questionnaires, Mechanical Temporal Summation assessment and pain threshold assessment will be assigned to patient. Within this cohort, some patients will have high pain score recorded (persistent pain) during the follow-up evaluations at 4 and 6 months.
干预措施: Pain threshold assessment (Other)
结局指标
主要结局
Persistent pain at 4 months after surgery
时间窗: 4 months after surgery
Persistent pain is defined as having one of the below criteria at 4 months after surgery: i) having pain score at rest (Numeric Rating Scale 0 to 100) of 30 or more; or ii) having pain score on movement (Numeric Rating Scale 0 to 100) of 30 or more; or iii) or "yes" to one of the seven questions on the presence of pain in daily life activities (mood, walking, carrying heavy loads, work, relations with people, sleep, enjoyment of life)
次要结局
- Maximum Acute post-operative pain score(Up to 3 days after surgery)
- Persistent pain at 6 months after surgery(6 months after surgery)
- Opioid consumption(Up to 3 days after surgery)
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital