The Effect of Pectoralis Block on Analgesia After Simple Mastectomy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of Recovery-27 score at baseline
研究概览
简要总结
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
详细描述
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
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)
盲法说明
Participants, care providers, investigators, and observers who record central measurements will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health)
- •Patients undergoing simple mastectomy
排除标准
- •-Patient Refusal
- •Allergy to local anesthetics
- •Inability to communicate in English
- •Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery
- •Existing nerve injuries or sensory deficits
- •Conversion to anesthesia via an endotracheal tube
研究组 & 干预措施
Pectoralis Block with Ropivacaine
General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)
干预措施: Pectoralis block (Procedure)
Pectoralis Block with Ropivacaine
General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)
干预措施: Ropivacaine Injection (Drug)
Pectoralis Block with normal saline
General anesthesia + Pectoralis block with 30ml of normal saline injection
干预措施: Pectoralis block (Procedure)
Pectoralis Block with normal saline
General anesthesia + Pectoralis block with 30ml of normal saline injection
干预措施: Normal saline injection (Drug)
结局指标
主要结局
Quality of Recovery-27 score at baseline
时间窗: Baseline
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline
Quality of Recovery-27 score at post operative day 1
时间窗: Post operative day 1
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1
Quality of Recovery-27 scores at post operative day 7
时间窗: Post operative day 7
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7
Quality of Recovery-27 scores at post operative day 30
时间窗: Post operative day 30
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30
Quality of Recovery-27 scores at post operative day 90
时间窗: Post operative day 90
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90
次要结局
- Comparison of Numerical Rating Scale-11 (NRS-11) at rest(90 days)
- Comparison of Numerical Rating Scale-11 (NRS-11) with movement(90 days)
- Duration of postoperative analgesia(Up to 24 hours)
研究者
Uma Shastri
Assistant Professor of Anesthesiology
Vanderbilt University Medical Center