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临床试验/NCT01322061
NCT01322061已完成4 期

The Role of a Single Oral Dose (2g) of Vitamin C in Reducing Intensity of Pain and Opioids Consumption in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized, Double-blinded, Placebo-controlled Study

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
total morphine consumption

研究概览

简要总结

Opioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side effects when used on short-term basis, has been shown to have promising analgesic effects in chronic pain and acute pain relief following orthopedic surgeries.

The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C in reducing the intensity of pain and the consumption of opioids in patients undergoing laparoscopic cholecystectomy at AUB-MC.

All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in the study. Patients will be randomized into two groups to receive either single dose oral vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both the patients and the investigation team will be blinded to the type of intervention. Intraoperative anesthesia management will be similar for both groups. Postoperative pain control will be achieved with patient controlled analgesia via a patient controlled morphine pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C concentration will be determined for each patient.

Patients demographics will be obtained and compared between both groups. The differences in pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and patient satisfaction scales will be compared between the two groups with the Student-t test, the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak vitamin C plasma concentration will be correlated with the pain scores in each group using regression analysis.

This study will provide relevant information on whether a single dose (2g) of vitamin C can reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus eliminating their side effects in patients undergoing laparoscopic cholecystectomy.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both gender
  • Between 18-75 years old
  • ASA class I, II, or III
  • Scheduled to undergo laparoscopic cholecystectomy

排除标准

  • Intake of anti-inflammatory drug in the past 24 hr
  • Allergy to morphine
  • History of chemical dependence
  • Chronic pain state
  • Inability to use PCA pumps
  • History of obstructive sleep apnea
  • History of severe asthma
  • History of COPD
  • History of gastroesophageal reflux disease

研究组 & 干预措施

Vitamin C

Active Comparator

干预措施: Ascorbic Acid (Drug)

mirinda

Placebo Comparator

干预措施: Ascorbic Acid (Drug)

结局指标

主要结局

total morphine consumption

时间窗: total morphine consumption in 24 hours

During their stay in the PACU (Post Anesthesia Care Unit), patients in both groups will be started on a morphine IV PCA pump that is programmed to deliver on patient's demand 1mg every 6 minutes with a total limit of 30mg every 4 hours for post operative relief.Patients will be followed up after discharge from PACU and morphine consumption will be recorded

次要结局

  • sedation score on the Ramsey scale(Sedation score will be measured in PACU and up 24 hours upon discharge from PACU)
  • incidence of nausea and vomiting(Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU)
  • Incidence of itching(Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU)
  • patient satisfaction scale(patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU)
  • Pain score on the Visual Analog Scale(Pain will be measured in PACU and up to 24 hours upon discharge from PACU)

研究者

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

Ghassan Kanazi

Associate Professor

American University of Beirut Medical Center

研究点 (1)

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