A Prospective Randomized Clinical Trial Comparing the Transversus Abdominis Plane Block (TAP) Versus Epidural Anesthesia For Enhanced Recovery Pathway Perioperative Management of Pain in Elective Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Post-operative Mean Numeric Pain Scale.
研究概览
简要总结
The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.
详细描述
Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery.
This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.
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
- •Patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum;
- •Surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic);
- •Patients > 18 years of age;
- •Able to provide informed written consent
- •Patients capable of completing questionnaires at the time of consent
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, elevated International Normalized Ratio (INR), anticoagulation, patient refusal, etc) or TAP block (patient refusal);
- •Urgent or emergent surgery precluding epidural catheter placement or TAP block;
- •Systemic Infection contraindicating epidural catheter placement or TAP block;
- •Unwillingness to participate in follow up assessments;
- •Prisoners
- •Pregnant women
研究组 & 干预措施
TAP Block- Exparel
Transversus abdominis plane block utilizing the medication Exparel®
干预措施: TAP Block (Procedure)
Continuous Epidural Analgesia
Continuous Epidural Analgesia
干预措施: Continuous Epidural Analgesia (Procedure)
结局指标
主要结局
Post-operative Mean Numeric Pain Scale.
时间窗: Post-operative day 0,1,2,3
Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale 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". Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.
Overall Benefits of Analgesia Score (OBAS)
时间窗: Post-operative day 0,1,2,3
Measured by the patient completing the OBAS survey on postoperative days 0,1,2,3. The OBAS is a multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy. 1\. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2-6. Grade any distress and bother from vomiting in the past 24 h (0=not at all to 4=very much: same scale for remaining Qs about itching, sweating, freezing, dizziness on the scale). 7\. Rate your satisfaction with your pain treatment on a scale between 0=not at all and 4= very much To calculate the OBAS score, compute the sum of scores in items 1-6 and add the '4-(score in item 7)'. The range of scores is from 0 (best) to 28 (worst). Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.
次要结局
- Patient Use of Narcotic Analgesia Post-op Day 0(Post-operative day 0)
- Patient Use of Narcotic Analgesia Post-operative Day 0(Post-operative day 0)
- Patient Use of Narcotic Analgesia Post-operative Day 3(Post-operative day 3)
- Patient Use of Narcotic Analgesia Post-operative Day 1(Post-operative day 1)
- Patient Use of Narcotic Analgesia Post-operative Day 2(Post-operative day 2)
研究者
Robert K Cleary
Colon and Rectal Surgeon
Trinity Health Michigan