The Use of Intravenous Dexamethasone for Post-operative Pain After Cesarean Delivery Under Neuraxial Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Score (VAS) 6 hours post-operatively at first rise
研究概览
简要总结
After surgery pain in women who have had a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Insufficient pain relief can lead to longer hospitalization and long term pain, which can result in long term use of pain medication. A classic method to alleviate pain after cesarean delivery is by injecting morphine into the spinal fluid, in the women's back, in addition to prescribing morphine by mouth as needed after the surgery. However, the negative effects associated with morphine and morphine-like drugs, limit the doses used, their pain relief capacity, and can negatively affect the after surgical experience of women. An approach which uses pain relief that acts on different pain pathways to treat after surgery pain helps limit the negative effects of different drugs. The potential benefit of dexamethasone as pain relief in women who have had a cesarean delivery is all the more interesting because of its minimal negative effects compared to morphine-like drugs. Its low cost, its effectiveness to prevent nausea, and its impact on the general condition of patients make dexamethasone even more attractive.
详细描述
Postoperative pain in patients who have undergone a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Suboptimal analgesia can lead to prolonged hospitalization and chronic pain, which can result in chronic use of pain medication. Treatment of post-operative pain after cesarean delivery uses intrathecal morphine, and the use of opioids as needed post-operatively. However, the side effects associated with opioids limit the doses used, their analgesic efficacy, and adversely affect the postoperative experience of patients. The multimodal approach to postoperative pain allows for analgesia that acts on different pain mechanisms while limiting the adverse effects of different drugs. The potential benefits of dexamethasone as a co-analgesic in women who have had a cesarean section are all the more interesting because of its minimal adverse effects compared to opioids. Its low cost, its effectiveness as antiemetic prophylaxis, and its impact on the general condition of patients make dexamethasone even more attractive.
In this randomised controlled trial, 100 patients are to be recruited and randomised to one of two groups. Both groups will receive standard treatment. In addition to standard treatment, the first group will receive dexamethasone 8 mg IV after umbilical cord clamping and the other group will receive a placebo.
The patients will be followed for 24 hours post-operatively. Their pain levels at rest and during movement will be recorded on an 11 point pain scale. The dose of hydromorphone used in the first 24 hours will be recorded. The patients are also asked to complete the QOR-40 questionnaire, which aims to assess the quality of their postoperative recovery. The primary outcome is the pain on an 11 point scale at the first rise 6 hours post-operatively.
The investigators hypothesize that dexamethasone will improve pain scores and diminish opioid use in the first 24 hours post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Cesarean delivery
- •Planned spinal or combined neuraxial anesthesia
- •Presence of an investigator in the delivery room
- •Pregnancy > 34 weeks gestation
排除标准
- •Cesarean delivery under general anesthesia
- •Inability to understand French or English
- •Allergy or hypersensitivity to dexamethasone
- •Allergy to hydromorphone
- •Allergy to NSAIDs
- •Acute kidney injury or chronic kidney failure
- •Preeclampsia
- •Extremely urgent cesarean section
- •Urgent cesarean section with non-reassuring fetal monitoring
- •Known maternal heart disease
- •High-grade placental abnormality
- •Diabetes (pregnancy or pre-existing)
- •Systemic infection, sepsis, fever
- •Regular use of dexamethasone in the last year
- •Weight greater than 120 kg and less than 70 kg
- •Height less than 150 cm
- •Chronic pain and/or chronic use of opioids
研究组 & 干预措施
Placebo
Participants who receive 0.9% saline IV (2 ml) 5 min after cord clamping.
干预措施: Placebo (Drug)
Dexamethasone
Participants who receive dexamethasone 8 mg IV (2 ml) 5 min after cord clamping.
干预措施: Dexamethasone (IV) (Drug)
结局指标
主要结局
Visual Analog Pain Score (VAS) 6 hours post-operatively at first rise
时间窗: 6 hours post-operatively
Visual Analog Pain Score (VAS), from 0 to 10, when patients first stand out of bed 6 hours post-operatively. A score of 0 on 10 being no pain, and a score of 10 on 10 being the worst pain imaginable.
次要结局
未报告次要终点
研究者
Valerie Zaphiratos
Associate Professor of Anesthesiology
St. Justine's Hospital