Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study
The control of postoperative pain has become a major issue in surgery awareness and it is considered an important measurement of patient satisfaction. Improvements in pain relief, including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to the surgical patient. When pain is aggressively addressed, patients respond by recovering faster.
The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting local anesthetic wound infiltration has been widely recognized as a useful adjunct to multimodal postoperative pain management. On that basis, a system that delivers a continuous local anesthetic to the surgical wound was developed, and better pain control has been achieved after several surgical procedures.
In patients undergoing abdominal procedures, such as colon resection, adequate pain control remains an issue. It is known that innervation to the antero-lateral abdomen is provided by sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been described and has shown to be effective for immediate postoperative pain control.
Recently, the use of the On-Q pain relief system with catheters placed within the TAP has been evaluated. Published results have shown significant improvement of pain control (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of prospective trials investigating the effectiveness of a continuous wound infusion with local anesthetics after general surgery procedures the investigators sought to determine the efficacy of this technique after laparoscopic colon resection procedures.
研究概览
研究类型
阶段
- 第三阶段
联系人和位置
学习地点
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Connecticut
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Stamford、Connecticut、美国、06904
- Stamford Hospital
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Stamford、Connecticut、美国、06902
- Colon and Rectal Surgery
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
- Patients must be able to read and write English.
Exclusion Criteria:
- Patients undergoing open procedures.
- Lap converted to open procedures.
- Patients with known liver dysfunction, or the following laboratory assays: ALT/AST/alk. Phos/total bilirubin of 2x ULN
- Cirrhosis Child's class A-C, INR >1.5. There is no specific isolated value of protein or albumin which would disqualify the subject.
- All emergent/urgent cases taken to the OR for colon resections.
- All patients with previous drug abuse/narcotic abuse history.
- Patients without the mental capacity to consent for the procedure/study.
- Subjects requiring a translator in order to sign the informed consent.
- Subjects with a history of an allergic reaction to local anesthetics or acetaminophen.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Ropivacaine
Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine
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On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
其他名称:
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安慰剂比较:Saline
Subjects with TAP catheters attached to the On-Q pump with saline
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On-Q pumps containing saline to be attached to TAP catheters
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to flatus
大体时间:1 week
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Post-operative time measurement for the patient to pass flatus
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1 week
|
|
Hospital Length of Stay
大体时间:1 week
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Post-operative time measurement until patient discharge
|
1 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Passage of Stool
大体时间:1 week
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Post-operative time measurement for the patient to pass stool
|
1 week
|
|
Narcotic use
大体时间:1 week
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Post-operative measurement of patient narcotic requirements
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1 week
|
合作者和调查者
出版物和有用的链接
一般刊物
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
- De Oliveira GS Jr, Fitzgerald PC, Marcus RJ, Ahmad S, McCarthy RJ. A dose-ranging study of the effect of transversus abdominis block on postoperative quality of recovery and analgesia after outpatient laparoscopy. Anesth Analg. 2011 Nov;113(5):1218-25. doi: 10.1213/ANE.0b013e3182303a1a. Epub 2011 Sep 16.
- Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.
- Gupta A, Fant F, Axelsson K, Sandblom D, Rykowski J, Johansson JE, Andersson SO. Postoperative analgesia after radical retropubic prostatectomy: a double-blind comparison between low thoracic epidural and patient-controlled intravenous analgesia. Anesthesiology. 2006 Oct;105(4):784-93. doi: 10.1097/00000542-200610000-00025.
- Raue W, Haase O, Junghans T, Scharfenberg M, Muller JM, Schwenk W. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc. 2004 Oct;18(10):1463-8. doi: 10.1007/s00464-003-9238-y. Epub 2004 Aug 26.
- Chester JF, Ravindranath K, White BD, Shanahan D, Taylor RS, Lloyd-Williams K. Wound perfusion with bupivacaine: objective evidence for efficacy in postoperative pain relief. Ann R Coll Surg Engl. 1989 Nov;71(6):394-6.
- Faucett J, Gordon N, Levine J. Differences in postoperative pain severity among four ethnic groups. J Pain Symptom Manage. 1994 Aug;9(6):383-9. doi: 10.1016/0885-3924(94)90175-9.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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