Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Hypotension
研究概览
简要总结
The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing major surgery. The two methods being compared are the thoracic epidural and the TAP block. The thoracic epidural method involves medication being given through a patient's back and the TAP block involves medication being given through a patient's abdomen (belly). The investigators will compare side effects experienced by the patients that take part in this study, including a change in blood pressure, as well as the patients' opinions about their pain management experience after surgery.
详细描述
The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method.
This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study.
Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care.
Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.
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
- None
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
- •All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures
- •Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures
- •Patient agrees to participate in this study and provides informed consent
- •Exclusion criteria:
- •Surgical cases combined with thoracic surgeries
- •Surgical cases where the abdominal operation is performed laparoscopically
- •Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone
- •Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin
- •Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations)
- •Adults unable to provide informed consent
- •Pregnant women
- •Prisoners
- •Non-English speaking subjects
- •Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study
排除标准
- 未提供
研究组 & 干预措施
Transversus Abdominis Plane Block
Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)
干预措施: Exparel 1.33% (20ml Volume) (Drug)
Thoracic Epidural Anesthesia
Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl
干预措施: 0.125% bupivicaine with 2 mcg/ml Fentanyl. (Drug)
结局指标
主要结局
Hypotension
时间窗: First 24-72 hours postoperatively
The incidence of systolic blood pressure less than 90 mmHg and fluid requirements
次要结局
- Patient satisfaction relative to pain control and amount of additional narcotic usage(Post operative day two during hospitalization)