Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Postoperative Numerical Pain Score-Day 0
研究概览
简要总结
This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver Soaker™ catheters (CPA) is equivalent to continuous epidural analgesia (CEA).
详细描述
Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. These techniques, however, are labor-intensive and expensive. Alternatively, local analgesics may be administered directly to the surgical wound via silver catheters.
Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use.
Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. The primary outcomes are post-operative pain control and supplemental narcotic usage.
Other variables of interest
- Surgical site infections
- The post-operative time to return of bowel function
- The hospital expenses/cost differences
- Quality of life measured with the Short Form (SF)- 36 questionnaire
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
- •Scheduled for elective colon or rectal surgery
- •Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic)
- •Able to provide informed consent
- •Able to complete patient questionnaire
排除标准
- •Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl
- •Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc)
- •Urgent surgery precluding epidural catheter placement
- •Systemic Infection contraindicating epidural catheter placement
- •Unwillingness to participate in follow up assessments
- •Prisoners
结局指标
主要结局
Postoperative Numerical Pain Score-Day 0
时间窗: Post-operative day 0
Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Postoperative Numerical Pain Score-Day 1
时间窗: Post-operative day 1
Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Postoperative Numerical Pain Score-Day 2
时间窗: Post-operative day 2
Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)
时间窗: After surgery in the post-anesthesia care unit
Postoperative NPS is a pain screening tool, commonly used to assess the pain severity a patient experiences after surgery, where "0" indicates no pain and "10" represents the worst pain imaginable".
Postoperative Numerical Pain Score-Day 3
时间窗: Post-operative day 3
Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Postoperative Numerical Pain Score-Day 4
时间窗: Post-operative day 4
Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
次要结局
- Patient Use of Supplemental Narcotic Analgesia Day 4(Post-operative day 4)
- Patient Use of Supplemental Narcotic Analgesia Day 1(Post-operative day 1)
- Patient Use of Supplemental Narcotic Analgesia Day 2(Post-operative day 2)
- Patient Use of Supplemental Narcotic Analgesia Day 3(Post-operative day 3)
- Patient Use of Supplemental Narcotic Analgesia Day 0(Post-operative day 0)