跳至主要内容
临床试验/NCT04416386
NCT04416386已完成不适用

Does Vitamin C Level Effect Postoperative Analgesia in Orthognathic Surgery: a Preliminary Study?

Medipol University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Blood plasma levels of vitamin C

研究概览

简要总结

Comparing the pre and post-operative blood plasma levels of vitamin C according to oxidative stress and investigate the correlation between post-operative analgesia requirement and vitamin C levels following orthognathic surgery.

详细描述

Vitamin C (ascorbic acid) is a water-soluble vitamin that has many functions include antioxidant, neuroprotective, neuromodulator and co-factor for various enzymes or chemical reactions. Primarily ascorbic acid is the most potent non-enzymatic antioxidant agent in an extracellular fluid which is crucial for defense against oxidative stress. Recent clinical studies have shown that trauma or surgery may lead to oxidative stress and plasma vitamin C level decreases due to body demand that most likely caused by oxidative stress.

Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. One of the major purposes in the management of post-operative pain is to minimize the dose of medications to reduce side effects while providing adequate analgesia.

In orthopedic surgery and management of postherpetic neuralgia oral vitamin C supplementation significantly reduced pain. However, the decrease in vitamin C concentration,the effects on antinociception and postoperative pain are not fully understood.

In this study, investigators aimed to compare pre and post-operative blood plasma levels of vitamin C after orthognathic surgery and investigate a correlation between post-operative analgesia requirement and vitamin C levels without vitamin C administration.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for orthognatic surgery under general anesthesia

排除标准

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedure

结局指标

主要结局

Blood plasma levels of vitamin C

时间窗: Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours

Pre and post-operative blood plasma levels of vitamin C

次要结局

  • Opioid consumption(Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahadir Ciftci

Principal Investigator

Medipol University

研究点 (1)

Loading locations...

相似试验