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临床试验/NCT03023501
NCT03023501已完成2 期

The Effect of Gabapentin on Postoperataive Pain ,Morphine Sparing Effect and Preoperative Anxiety in Bariatric Surgical Patients

King Saud University0 个研究点目标入组 50 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
主要终点
Post operative pain

研究概览

简要总结

The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties.This study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

详细描述

Research Problem: Laprocopic sleeve gastrectomy is the most common surgical procedure performed for reducing weight in morbidly obese patients. Laparoscopic surgery is considered to be less invasive than open surgery. The treatment of pain in obese patients is a challenge. Administering opioids, can have an increasing effect of respiratory depression in patients already at risk of sleep apnea. The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties. The analgesic effect of gabapentin appears to be related to the surgical procedure undertaken, a more procedure-specific evaluation is needed for different types of surgeries..

Research Significance: This study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

Research Objectives: To evaluate the effect of preoperative administration of gabapentin on postoperative pain, postoperative morphine consumption and preoperative anxiety in patients coming for laparoscopic sleeve gastrectomy.

Research Methodology:

Inclusion criteria: ASA I and II, Age 18-50 years, either sex, Planned Surgical procedure laparoscopic sleeve garstectomy, BMI 30-45 . Exclusion criteria: Patients taking any sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, Methods Patients will be randomly assigned into two groups, Group-Control and , Group- Gabapentin of 25 each. Anesthesia and postoperative course will be standardized. VAS scale will be used for assessment of preoperative anxiety and postoperative pain. Post operatively pain assessment and morphine consumption will be performed for 24 hours in PACU and ward

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA 1 and 2
  • BMI 35 - 45

排除标准

  • Patients taking any sedative or tranquillizers
  • Any contraindication to gabapentin.

研究组 & 干预措施

Gabapentin

Experimental

Gabapentin 1200mg capsule was administered orally 2 hours before surgery

干预措施: Gabapentin (Drug)

Placebo

Placebo Comparator

Placebo capsule was prepared by hospital pharmacy and was administered orally 2 hours before surgery.

干预措施: Placebo Oral Capsule (Drug)

结局指标

主要结局

Post operative pain

时间窗: 4 hourly in the ward for 24 hours

Post operative Morphine requirement

时间窗: 4 hourly in the ward for 24 hours

次要结局

  • Preoperative anxiety(30 minutes before surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MUEEN ULLAH KHAN

MUEEN ULLAH KHAN

King Saud University

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