Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane Block After Cesarean Delivery in Patients With a BMI > 30
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery
研究概览
简要总结
The purpose of this study is to determine if injecting a local anesthetic, or numbing medication, above each hip will decrease the amount of narcotic pain medicine that is typically required by a patient after a cesarean delivery. Ultrasound pictures will be used to guide placement of this injection. Either ropivicaine (a type of numbing medication called a local anesthetic) or a placebo (saline) will be injected. For 24 hours, you will be given a button to press when you have pain. When the button is pressed, you will be given a small amount of pain medication called hydromorphone through your IV. You will also be given a pain medication called ketorolac through your IV every 8 hours for 24 hours after 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 18 years or over
- •ASA class 1 , 2 or 3
- •BMI greater than 30 kg/m2 (as recorded at the patient's last clinic appointment or as measured on the day of delivery)
- •Scheduled for cesarean section via Pfannenstiel incision (with or without a tubal ligation)
- •150 cm or taller
- •Informed consent obtained
排除标准
- •ASA class 4
- •Age under 18
- •Relevant drug allergy
- •Contraindication to spinal anesthesia
- •Height < 150 cm
- •Patient receiving medical therapies considered to result in a tolerance to opioids
- •Any other major surgical procedure performed other than cesarean delivery with or without tubal ligation
- •Patient with relevant contraindications to ketorolac, such as history of gastrointestinal bleeding or impaired renal function
- •Patient refusal
研究组 & 干预措施
20 ml per side of 0.5% ropivacaine
Ultrasound guided TAP blocks will be performed once patient is in the recovery area. Patients will be placed on their back with their hands resting comfortably above their head. Using an ultrasound guided technique, the ultrasound probe will be positioned on abdominal until the three lateral abdominal wall muscles and TAP are clearly imaged. A two or four inch, 20 gauge needle will be advanced using an in-plane technique. After visual confirmation that the needle tip is in the TAP, 1 ml of preservative free 0.9% sodium chloride will be injected to reconfirm correct placement in the TAP. Then 20 ml of 0.5% ropivacaine will be injected. The procedure will be repeated on the other side.
干预措施: 0.5% ropivacaine (Drug)
20 ml per side of 0.9% sodium chloride
Ultrasound guided TAP blocks will be performed once patient is in the recovery area. Patients will be placed on their back with their hands resting comfortably above their head. Using an ultrasound guided technique, the ultrasound probe will be positioned on abdominal until the three lateral abdominal wall muscles and TAP are clearly imaged. A two or four inch, 20 gauge needle will be advanced using an in-plane technique. After visual confirmation that the needle tip is in the TAP, 1 ml of preservative free 0.9% sodium chloride will be injected to reconfirm correct placement in the TAP. Then 20 ml of 0.9% preservative free sodium chloride will be injected. The procedure will be repeated on the other side.
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery
时间窗: 24 hours
次要结局
- Categorical pain scores and Visual Analog Scale (VAS) pain scores (at rest and with movement), nausea and sedation will be assessed to evaluate narcotic side effects(24 hours)
研究者
Stuart Hart
Director of Obstetric Anesthesiology
Ochsner Health System