Comparing the Quality of Recovery(QoR) of Pectoral Nerves(PECS) Block and General Anesthesia(GA) in Breast-conserving Surgery(BCS) With Sentinel Lymph Node Biopsy(SLNB):A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Postoperative QoR-15 at 6 hours
研究概览
简要总结
The aim of this randomized controlled trial (RCT) is to assess the Quality of Recovery (QoR) in Breast-conserving Surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) using Pectoral Nerves (PECS) Block and General Anesthesia (GA). The primary objectives are as follows: First, to determine if the PECS group exhibits better QoR; Second, to investigate if the PECS group experiences less postoperative pain and complications; Third, to examine if the PECS group demonstrates more stable hemodynamics.
详细描述
This study is a randomized controlled trial, with a 1:1 ratio for grouping. The experimental group is the T group, receiving Pecs II combined with intercostal nerve block, while the control group is the C group, receiving general anesthesia. The primary outcome measure is the QoR-15 score of the subjects 6 hours after surgery. Based on preliminary results, the control group had a QoR-15 score of 133±8 (n=6), and the experimental group needs to improve by at least 8 points (which is generally considered clinically significant, PMID:27159009). With a two-sided α=0.05 and a power of 99%, accounting for a 20% dropout rate, the final required sample size was calculated to be 96 cases, with 48 cases in each group.
If the proportion of dropout cases is less than 5% and considered "completely random missing," the missing records generated by the dropout cases will be directly excluded. Depending on the specific circumstances, either single imputation or multiple imputation methods will be used.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
The follow-up personnel and data analysts are blind.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for breast-conserving surgery with sentinel lymph node biopsy.
- •Age between 18 and 70 years.
- •Body Mass Index (BMI) < 30 kg/m
- •American Society of Anesthesiologists (ASA) classification grade I-III.
排除标准
- •Contraindications to regional anesthesia: site infection at the puncture site, allergy to local anesthetics, coagulation disorders, or bleeding risks.
- •Impaired liver or kidney function.
- •Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.
- •Preoperative use of analgesic drugs, history of chronic pain, or history of opioid abuse.
- •Mental illness.
- •Patients who refuse to participate.
- •Patients deemed unsuitable for the clinical trial by the researchers.
结局指标
主要结局
Postoperative QoR-15 at 6 hours
时间窗: 6 hours after the surgery
The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.
次要结局
- The number of patients who experience intraoperative hypotension(From the beginning of anesthesia to the end of the surgery.)
- Changes in hemodynamics (mean arterial pressure) after the surgical incision.(From the beginning of anesthesia to three minutes after the surgical incision.)
- Changes in hemodynamics (heart rate) after the surgical incision.(From the beginning of anesthesia to three minutes after the surgical incision.)
- Postoperative NRS pain score at 6 hours(6 hours after the surgery)
研究者
Jun Zhang
Head of Department of Anesthesiology, Fudan University Shanghai Cancer Center
Fudan University