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临床试验/NCT01592630
NCT01592630撤回3 期

Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study

Stamford Hospital2 个研究点 分布在 1 个国家开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
试验地点
2
主要终点
Time to flatus

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
  • Patients must be able to read and write English.

排除标准

  • 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.
  • 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.

研究组 & 干预措施

Ropivacaine

Experimental

Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine

干预措施: 0.2% ropivacaine (Drug)

Saline

Placebo Comparator

Subjects with TAP catheters attached to the On-Q pump with saline

干预措施: Saline (Drug)

结局指标

主要结局

Time to flatus

时间窗: 1 week

Post-operative time measurement for the patient to pass flatus

Hospital Length of Stay

时间窗: 1 week

Post-operative time measurement until patient discharge

次要结局

  • Passage of Stool(1 week)
  • Narcotic use(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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