The Effect of Intra-operative Intravenous Vitamin C Supplementation on post-operative pain in patients undergoing Reconstructive Head and Neck Flap Surgeries: A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the effect of Vitamin C supplementation in postoperative pain (VAS score at 6 hours) in patients undergoing reconstructive Head and Neck flap surgeries (local and pedicled flap).
研究概览
简要总结
Pain is defined by the International Association for the Study of Pain (IASP) as An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. It is a complex phenomenon that includes both sensory-discriminative and motivational-affective components. The sensory discriminative component of pain depends on ascending projections of tracts (Spinothalamic tracts) to the cerebral cortex. The motivational affective responses to painful stimuli include attention and arousal, somatic and autonomic reflexes, endocrine responses and emotional changes.
Postoperative pain is present in up to 80 percentage of patients undergoing surgery, and is of significant concern. It impairs the quality of life (such as sleep quality and level of activity) and impacts patient recovery, opioid consumption, and overall hospital stay and contributes to chronic postoperative pain.
The commonly used postoperative analgesic agents include opioids and nonsteroid anti inflammatory drugs (NSAIDs) are associated with untoward side effects including respiratory depression and other complications such as nausea or vomiting. In addition, NSAIDs, which are usual adjuvants to opioid-based regimens, are known to contribute to adverse gastrointestinal, renal side-effects and bleeding.
The goal of this study is to evaluate the effectiveness of intravenous Vitamin C in reducing pain. Vitamin C, the L enantiomer of ascorbate also known as ascorbic acid, is a water-soluble antioxidant ubiquitously present in a variety of fruits and vegetables. The importance of vitamin C in wound healing and hemostasis was first realized more than 260 years ago when it was found to be a cure for scurvy, a disease characterized by spontaneous bleeding, anemia, and gum ulceration. Besides its role in hemostasis, vitamin C is also known to exhibit analgesic functions. Recent evidence has attributed the antinociceptive action of Vitamin C to its antioxidant, neuroprotective, and neuro-modulatory properties. Vitamin C has been shown to reduce acute pain and the prevalence of complex regional pain syndromes (CRPS) with its antinociceptive effect. Considering that intravenous vitamin C can trigger oxidative hemolysis with glucose 6 phosphate dehydrogenase (G6PD) deficiency, we will be screening the patients for G6PD activity prior to their inclusion in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 17.00 Year(s) 至 64.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who give consent for head and neck flap (local and pedicle) surgery and intravenous Vitamin C ASA 1 and ASA 2 G6PD normal patients Hemodynamically stable patients undergoing head and neck reconstructive flap surgeries.
排除标准
- •Age below 17 years and above 65 years Patient who refuse to be a part of the study ASA 3 and above patients (cardiac and renal failure patients) Pregnant women G6PD deficient patients Patient with history of allergy to Vitamin C History of chronic opioid use.
结局指标
主要结局
To assess the effect of Vitamin C supplementation in postoperative pain (VAS score at 6 hours) in patients undergoing reconstructive Head and Neck flap surgeries (local and pedicled flap).
时间窗: 6 hours postoperatively
次要结局
- VAS score at 0,12 and 24 hours postoperatively(0,12 and 24 hours)
- Time to rescue analgesic request(Till 24 hours postoperatively)
- Measure the amount of postoperative analgesic requirement(Till 24 hours postoperatively)
- To evaluate the length of hospital stay(Date of discharge)
研究者
Dr Jassica Charles
Christian Medical College Vellore
