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临床试验/NCT00886236
NCT00886236已完成不适用

The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2008年2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
已完成
入组人数
62
试验地点
1
主要终点
Number of Participants Who Experience Incidence of Postoperative Nausea.

研究概览

简要总结

The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its ability to reduce postoperative pain, the need for morphine-like pain medication, and the severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass surgery patients.

详细描述

The occurrence of morbid obesity is at epidemic proportions in the United States. Laparoscopic gastric bypass is an effective means of safely facilitating patient weight loss and thereby drastically reducing the prevalence and severity of many future health complications [1]. However, managing morbidly obese surgical patients poses certain obstacles for anesthesiologists, including a high incidence of obstructive sleep apnea [2].

Laparoscopic gastric bypass, like all surgical interventions, has associated postoperative challenges including pain management and prevention/control of postoperative nausea and vomiting. To assure the highest patient satisfaction, all areas of patient comfort must be addressed. However, with pain management in morbidly obese patients, caution must be used when administering opioids, as they can have an increasing effect of respiratory depression in patients already at risk due to obstructive sleep apnea [3]. Gastric bypass is also associated with a significant incidence of protracted postoperative nausea and vomiting [4]. Therefore, regimens that address both patient safety and patient comfort are desired.

Gabapentin (Neurontin) is an alkylated analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that has been FDA approved for the treatment of seizures, headaches fibromyalgia and chronic neuropathic pain due to various etiologies [5]. Many randomized controlled trials have been performed with perioperative gabapentin [6-10]. The effect of perioperative administration of gabapentin on postoperative pain and opioid consumption has been extensively studied and several meta-analyses have been published in the last several years examining to overall findings of these studies. The general consensus is that gabapentin has anti-hyperalgesic and opioid-sparing properties and may also reduce the incidence of postoperative nausea and vomiting [5, 11-15]. Most research has shown that gabapentin is beneficial in the treatment of postoperative pain, but some show neither positive nor negative effects. There has been no evidence that gabapentin is detrimental or poses any risks to the postoperative patient. However, gabapentin has not been specifically studied in bariatric surgery. Therefore, the purpose of this study is to explore the hypothesis that perioperative gabapentin has anti-hyperalgesic and opioid-sparing properties, thus increase patient comfort and satisfaction by decreasing pain scores and reducing the adverse effects of opioids, such as postoperative nausea and vomiting.

This is a randomized, double-blind and placebo controlled study, which will be performed in adult laparoscopic gastric bypass patients coming to surgery for morbid obesity. The major end-points of analyses are intraoperative and postoperative opioid requirements and the incidence of nausea and vomiting in the postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing laparoscopic gastric bypass surgery
  • Age > 18 years

排除标准

  • Patients under the age of 18 years
  • Patients who undergo open gastric bypass
  • Patients with a history of chronic pain treated with pregabalin, gabapentin or opioids
  • Patients with a history of chronic renal disease (creatinine > 1.3)
  • Patients with a history of bleeding gastric ulcer

研究组 & 干预措施

1 Preoperative Gabapentin Liquid

Active Comparator

Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)

干预措施: Gabapentin (Drug)

2 Preoperative and Postoperative Gabapentin Liquid

Experimental

Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)

干预措施: Gabapentin (Drug)

3 Preoperative and Postoperative Placebo Liquid

Placebo Comparator

Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants Who Experience Incidence of Postoperative Nausea.

时间窗: 120 hours

Evaluate the Amount of Diluadid Given Postoperatively

时间窗: 120 hours

The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms.

次要结局

  • Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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