Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Breast cancer is one of the most common types of cancer among women worldwide. (1) Breast-conserving surgery or mastectomy is indicated for the majority of patients with this type of cancer. (2) Postoperative pain is frequent in this population, with almost 50 % experiencing acute pain and 25-60 % subsequently live with chronic pain. (3-5) Today no golden standard for postoperative pain management regarding breast cancer surgeries exists, and there is definitely room for improvement. Especially considering the large population of women with breast cancer and consequences of acute and chronic pain, such as prolonged recovery and affected quality of life. (6,7) With the present study, we aim to optimise postoperative pain treatment and investigate the effect of a standardised multimodal postoperative analgesic regimen based on previous recommendations. (4,8,9)
详细描述
All patients scheduled for breast conserving surgery or mastectomy with or without ALND or SLNB at Zealand University Hospital, Roskilde, will be invited to participate in the study. When the patients arrive for preoperative preparation on the day of surgery, one of the investigators will be responsible for a thorough oral information regarding the purpose of the study and all relevant participation requirements. The conversation will take place in a closed room, and the informed consent form will be obtained if the patient decides to participate.
Furthermore, patients will be informed that participation is voluntary and that a wish for withdrawal will be granted immediately.
The informed consent will grant the investigators direct access to data in the patients' electronic files to ensure the information necessary for the study. The patients also consent to complete the questionnaires in the seven-day follow-up period, and that the investigators can reach them by phone.
Completion of the study It is considered a completion of the study when a patient has signed the informed consent, has followed the treatment regimen, and answered the questionnaires in the seven-day follow-up period.
If a patient does not complete the study, an account should be given as to whether and how this subject's data is handled in the study - this also replies to drop-outs.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for day-case unilateral breast conserving surgery or mastectomy +/- ALND or SLNB.
- •Age ≥ 18 years of age.
- •Patients who received written and oral information, and have signed the informed consent form on participation in the study.
- •Patients living in the Region of Zealand.
排除标准
- •Not able to speak, read, or understand Danish.
- •Inability to cooperate and to consent.
结局指标
主要结局
Postoperative pain
时间窗: Postoperative day 1 to 7.
Postoperative pain scored on the 11-point numeric rating scale, NRS, (score 0 = no pain, 10 = worst pain imaginable). Average pain, worst pain and pain during arm abduction to an angle of 90 degrees out from the body.
次要结局
- Quality of recovery, QoR-15D(Postoperative day 1 and 7.)
- Location of pain(Day of surgery (preoperative) and postoperative day 1 to 7.)
- Pain at the day-case post anaesthesia care unit (dcPACU)(From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours)
- Quality of sleep(Postoperative day 1 to 7.)
- Postanaesthesia recovery time(From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours)
- Postoperative nausea and vomiting(Postoperative day 1 to 7.)
- Daily use of analgesics(Postoperative day 1 to 7.)
- Well-being(Postoperative day 1 to 7.)