Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary outcome measurement will be the average pain with movement on postoperative day 1 as measured by 0-10 scale, where 0=no pain and 10=worst imaginable pain.
研究概览
简要总结
Research study to determine if putting local anesthetic through one or two tiny tubes next to the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will improve pain control following surgery. This study will also help determine if patients require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their postoperative pain control.
详细描述
Specific Aim: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in improved postoperative pain control.
Hypothesis 1: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in lower average pain scores during movement the day following surgery.
Specific Aim2: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, opioid use, sleep disturbances, and improved patient satisfaction.
Hypothesis 2: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, oral opioid consumption, sleep disturbances, and improved patient satisfaction the day following surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing ambulatory inguinal and/or abdominal surgery amenable to a Transversus Abdominis Plane nerve block (unilateral or bilateral).
- •expected postoperative pain to be at least moderate in severity the day following surgery
- •age 18 years or older
- •desires a regional anesthetic for postoperative analgesia
- •is able to understand the possible perineural infusion-related complications, study protocol, and catheter/pump care
- •has a caretaker through the first night after surgery
- •has an ASA Physical Status Classification of 1-3
排除标准
- •any contraindication for a continuous Transversus Abdominis Plane nerve block
- •any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- •current chronic opioid or tramadol use
- •history of alcohol or opioid abuse
- •know allergy or other contraindication to the study medication
- •pregnancy
- •known hepatic or renal insufficiency/disease
- •peripheral neuropathy of the surgical site
- •morbid obesity
- •inability to communicate with the investigators and hospital staff
- •incarceration
结局指标
主要结局
The primary outcome measurement will be the average pain with movement on postoperative day 1 as measured by 0-10 scale, where 0=no pain and 10=worst imaginable pain.
时间窗: 1 day
次要结局
- Pain with movement on second day following surgery, as measured by 0-10 scale (where 0=no pain and 10=worst imaginable pain).(2 days)
- Total opioid consumption per day following surgery as measured by the number of opioid pills consumed per day.(Day 1 and 2 following surgery)
- Sleep disturbances, measured on days 1 and 2 following surgery, as asked by research staff during follow-up phone calls.(Days 1 and 2 following surgery)
- Patient satisfaction of pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied with pain control(Day 2 following surgery)