Randomised Controlled Trial Comparing the Effect of Intravenous Dexamethasone vs. Placebo on the Duration of Analgesia of Spinal Anaesthesia for Caesarean Sections at the Victoria Jubilee Hospital in Jamaica
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
Dexamethasone is one of many adjuncts tested to prolong the duration of spinal anesthesia and its analgesic effect. The intent of this, a single-site, double-blinded, randomized controlled trial, is to determine if a single intravenous (IV) 8 mg dose of Dexamethasone given after clamping of the umbilical cord at Caesarean section will prolong the duration of analgesia provided by spinal anesthesia when compared to placebo. This has the power to determine if the findings in previous studies hold true in the population of women who undergo C-sections at the Victoria Jubilee Hospital. This method does not require expert skill and equipment, as such, it can be easily implemented, with no major adverse effects in the population described and provide an effective option for multimodal analgesia.
详细描述
This study is being conducted in accordance with the Good Clinical Practice guidelines as enunciated in the international Conference on Harmonization (ICP/GCP) of 2016 and the Declaration of Helsinki, 2013.
Sample Size:
The sample size calculated based on a study done by Shahraki et al who studied the efficacy of intravenous Dexamethasone in prolonging the duration of Spinal Anesthesia in elective Caesarean Section in an Indian population (36).
The following values were used for the calculation of the sample size: the required value of α was 5%, β was 10%, a clinically significant difference in Visual Analogue Scale (VAS) score at 1-hour post-surgery was considered 2 and the expected standard deviation was 2.5 (36). The equation used was:
n = (Zα/2+Zβ)2 *2*σ2 / d2,
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients at Victoria Jubilee Hospital in Jamaica, scheduled for non-emergent LSCS under spinal anesthesia
- •Age: 18 to 45 years
- •Gestational Age: 37 weeks or more
- •American Society of Anesthesiologists physical status class II
- •Singleton fetus
排除标准
- •Emergent Indication for caesarean section including, but not limited to:
- •Fetal distress
- •Cord prolapse
- •Eclampsia
- •Severe pre-eclampsia
- •Placental abruption
- •Placenta praevia
- •Multiple Gestation
- •Allergy to glucocorticoids/opioids/Diclofenac Na/ local anesthetics
- •Contra-indication to Spinal Anesthesia
- •Gestational Diabetes or Pre-gestational Diabetes
- •Other uncontrolled comorbidities (such as cardiac, respiratory, renal, inflammatory, endocrine disease)
- •Chronic steroid use
- •history of Peptic Ulcer Disease or Glaucoma
- •history of chronic pain
- •Illicit drug users (including marijuana)
- •Any patient who requires general anesthesia secondary to failure of spinal anesthesia will also be excluded
研究组 & 干预措施
Study Drug A
Dexamethasone 8mg intravenous administration stat dose post clamping of the umbilical cord
干预措施: Dexamethasone (Drug)
Study Drug B
Normal saline 2cc intravenous stat dose administered after clamping of the umbilical cord
干预措施: Placebo (Other)
结局指标
主要结局
Duration of analgesia
时间窗: first 4 hours after spinal anesthesia administered
The duration of time from the administration of drugs intrathecally for spinal anesthesia to the first request for analgesia or first time the pain score is greater than 4
次要结局
未报告次要终点
研究者
Renee Nesbeth
Dr.
The University of The West Indies