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临床试验/NCT02945696
NCT02945696撤回不适用

Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement

Marcus Malek0 个研究点开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Minutes under anesthesia

研究概览

简要总结

The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.

详细描述

Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11.

The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.

The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients 5 - 17 years old.
  • Patients undergoing laparoscopic procedures
  • Patients that weigh greater than or equal to 34 kg and less than 100 kg.

排除标准

  • Patients who underwent open surgical procedures will be excluded from this study.
  • Patients that weigh less than 34kg.
  • Patients that weigh more than 100 kg.
  • Perforated appendicitis.
  • Bowel obstruction

研究组 & 干预措施

Laparoscopic guided nerve blocks

Experimental

These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.

干预措施: laparoscopic guided nerve blocks (Procedure)

Laparoscopic guided nerve blocks

Experimental

These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Minutes under anesthesia

时间窗: 2 years

次要结局

  • Pain scores(2 years)
  • Narcotic usage(2 years)

研究者

发起方
Marcus Malek
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marcus Malek

Assistant Professor

University of Pittsburgh

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