Quality of Recovery Scores in Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block Versus Pectoral Nerves Block for Breast Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- the quality of recovery-15 questionnaire (QoR-15)
研究概览
简要总结
This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.
详细描述
The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female, 18-80 years of age
- •American Society of Anesthesiologists physical status I-III
- •patients having elective unilateral breast cancer surgery
排除标准
- •contraindication to nerve block
- •inability to understand or communicate with research personnel
- •chronic use of opioids or nonsteroidal anti-inflammatory drugs
- •pregnancy
结局指标
主要结局
the quality of recovery-15 questionnaire (QoR-15)
时间窗: at 24 hours after surgery
The QoR-15 is a validated short-form postoperative quality of recovery score. Fifteen questions assess five domains of patient health-related quality of life: pain; comfort; physical independence; psychological support; and emotional state. Each question uses an 11-point rating scale, in which the maximum score is 150, denoting excellent recovery. 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with family or friends 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed
次要结局
- the incidence of postoperative hypotension(during 48 hours after surgery)
- the incidence of pruritus(during 48 hours after surgery)
- NRS score for rest and coughing pain(at 1, 6, 24, 48 hours after surgery)
- the incidence of nausea and vomiting(during 48 hours after surgery)
- the block-related outcomes(through study completion, an average of 5-7 days)
- the Brief Pain Inventory(at 3 months after surgery.)
- postoperative hospital stay in days(through study completion, an average of 5-7 days)
- consumption of opioid converted to IV morphine equivalents(during 24 hours after surgery)
- the incidence of respiratory depression(during 48 hours after surgery)
- time to urethral catheter removal in hours(through study completion, an average of 24-36 hours)
- intra-operative opioid requirements(through the anesthesia process, an average of 1.5-2.5h)
研究者
Huifang Jiang
Principal Investigator
Zhejiang Cancer Hospital