Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Proportion of Participants With No Pain Immediately After Surgery
研究概览
简要总结
Primary Objective:
To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia.
Secondary Objectives:
- To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia.
- To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia.
- To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.
详细描述
Paravertebral Blocks and General Anesthesia The use of a paravertebral block involves injecting local anesthesia (a numbing medicine) into the patient's back to numb specific areas (the breast[s] for this study) for surgery.
General anesthesia is medicine that is used to put patients to sleep so that there is no feeling of pain.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. You will have an equal (50/50) chance of being assigned to either group.
Participants in one group will receive a paravertebral block (the local anesthetic ropivacaine) plus general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 that consent to participate
- •Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone
- •Patients that are female
- •Patients that are over the age of 18
- •Patients on anti-coagulants or other blood thinning medications will be eligible for inclusion if they stop taking these medications for at least the time specified below prior to date of surgery: Low molecular weight heparin must stop at least 36 hours prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix and NSAIDs must stop at least 7 days prior to surgery.
排除标准
- •Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)
- •Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's
- •Patients with BMI<20 or >40
- •Patients that are pregnant
- •Patients with chronic pain syndromes.
- •Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication
研究组 & 干预措施
Paravertebral Block + General Anesthesia
Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)
干预措施: Paravertebral Block (Procedure)
Paravertebral Block + General Anesthesia
Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)
干预措施: Ropivacaine (Drug)
General Anesthesia Alone
Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
干预措施: Propofol (Drug)
General Anesthesia Alone
Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
干预措施: Fentanyl (Drug)
General Anesthesia Alone
Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
干预措施: Midazolam (Drug)
结局指标
主要结局
Proportion of Participants With No Pain Immediately After Surgery
时间窗: Starting immediately after surgery, every 2 hours till the 6th hour following surgery
Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).
次要结局
未报告次要终点