Randomized Clinical Trial Comparing the Use of Perioperative Epidural Analgesia to Conventional Intravenous Narcotics and NSAIDS for Patients Undergoing Laparoscopic Colorectal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various pathology from diverticular disease to colon cancer. In comparison to conventional open surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower wound-related complication rates, better cosmetic results and earlier return to normal activities.
Despite the fact that laparoscopic colorectal surgery is done through smaller incisions, there is still a considerable amount of abdominal wall trauma with these procedures. This still can cause a significant amount of postoperative discomfort, which can add to patients' stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can be difficult to control and has been mainly managed pharmacologically with the use of narcotics and non-narcotic medications delivered through different routes. The effectiveness of pain control depends on the medication, its dosage, frequency and route of administration. The latter is mainly achieved through the intravenous route in the immediate postoperative period in laparoscopic colorectal surgery patient, as patients are restricted from having anything by mouth until return of bowel function.
Another route of delivery is the use of local anesthetics as well as opioids via an epidural catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia in obstetrics, to date there has been very few studies looking at the effectiveness of epidural analgesia in laparoscopic colorectal surgery.
The primary purpose of this study is to evaluate the impact of epidural analgesia as compared to conventional analgesia on the length of hospital stay in patients undergoing laparoscopic colorectal procedures. The secondary objectives of the study will be to evaluate patient satisfaction, quality of life, pain control and return of bowel function in patients treated with either epidural analgesia or intravenous narcotics.
详细描述
Laparoscopic colorectal surgery has now become the standard of care in the treatment of many colorectal pathologies. In comparison to open or conventional surgery it has the benefit of decreased length of hospital stay (1), reduced postoperative pain, earlier return of bowel function (2,3) , earlier return to normal activities and improved cosmetic results.
Several criteria must be met before patients are discharged from the hospital. These discharge criteria are the same objective criteria we use to discharge our surgical patients:
- Return of bowel function (as manifested by passage of flatus or bowel movement)
- Ability to tolerate a regular diet
- Stable vital signs for 24 hrs
- Good pain control on oral medications
- Ability to void freely
- Return to a similar level of preoperative functioning
All attending surgeons will strictly adhere to the above 6 criteria when discharging patients.
Poor pain control is known to increase the length of hospital stay after surgery. Good pain control thus becomes essential in order to decrease the length of hospital stay and make patients more comfortable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years
- •Subjects undergoing laparoscopic large bowel resection or rectal resection with anastomosis and/ or any type of ostomy (end, diverting)
- •University of California, Irvine Medical Center inpatients and outpatients scheduled for surgery
- •Elective surgery for benign and malignant conditions
排除标准
- •Emergency procedure including procedures done for bowel obstruction, constriction, fulminant inflammation
- •Infection
- •Patient participating in other trials that may affect the study outcome
- •Subjects with hypersensitivity to any of the anesthesia drugs used per Standard of Care at UCI Medical Center
- •Subjects with history of chronic pain
- •Pregnant patients or nursing females
- •Subjects with a history of severe cardiovascular, pulmonary, renal, hepatic, hematologic or systemic disease
- •Early Study Termination due to conversion to Open Surgery (subjects who were converted from laparoscopic to open surgery
- •Contraindication to epidural anesthesia (bleeding diathesis, severe hypovolemia, elevated intracranial pressure, infection at the site of injection, and severe stenotic valvular heart disease or ventricular outflow obstruction.
结局指标
主要结局
Length of Hospital Stay
时间窗: 1-7 days
The primary end point of the analyses is length of hospital stay from the date of admission for the surgical procedure to the day of hospital discharge.
次要结局
- Return of bowel function(1-7 days)
研究者
Nihn Tuan Nguyen
Professor and Interim Chair of Surgery
University of California, Irvine