A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- chronic breast pain at 1 year after mastectomy
研究概览
简要总结
In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.
详细描述
Study population
- All of patients will undergo mastectomy with or without immediate breast reconstruction.
- 230 patients will be enrolled.
Intervention
- OFA group will be sedated using dexmedetomidine and lidocaine.
- Conventional opioid anesthesia group will be sedated using remifentanil.
Pain screening
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
- Single (Participant)
盲法说明
Patients will be not aware of which type of anesthesia would be applied during operation.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All of patients will undergo mastectomy with or without immediate breast reconstruction.
排除标准
- •Previous history of breast surgery
- •Allergy to drug
- •Other cancer history
- •Underlying psychologic disorder
- •Patients with chronic pain requiring pain killers
- •Baseline SpO2 <95%
- •Left ventricular EF <40%
- •Bradycardia as HR <50 bpm
- •BMI >35kg/m2
- •Pregnant woman
研究组 & 干预措施
Opioid-free anesthesia group
OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.
干预措施: Opioid-free anesthesia (Procedure)
Conventional anesthesia group with opioid
Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.
干预措施: Conventional opioid-based anesthesia (Procedure)
结局指标
主要结局
chronic breast pain at 1 year after mastectomy
时间窗: 1 year after mastectomy
chronic pain will be assessed by Breast Cancer Pain Questionnaire (BCPQ). Zero score means absence of persisting breast-related pain. The minimum and maximum values of pain scale are 0 and 11, respectively. High score means worse outcome. Moderating role of preoperative psychosocial factors on the impact of OFA on chronic postoperative pain will be evaluated.
次要结局
- Pain Sensitivity(1 year after mastectomy)
- psychological symptoms(1 year after mastectomy)
- Pain Sensitivity(1 year after mastectomy)
研究者
Sung Gwe Ahn
Assocaite Professor
Gangnam Severance Hospital