Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Morphine Consumption at 24 Hours Post-op
研究概览
简要总结
The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.
详细描述
Steroids have been used to reduce inflammation and tissue damage in a variety of conditions, have potent immunomodulatory effects, and are a mainstay in the treatment of acute allograft rejection. Dexamethasone has been shown to be a safe and effective anti-emetic therapy for patients undergoing cesarean section surgery with spinal anesthesia containing morphine.
However, recent evidence suggests that dexamethasone may also play a role in reducing post-operative pain and opioid consumption. Early studies in patients undergoing dental procedures showed that glucocorticoids were effective in reducing postoperative pain and edema. Multiple recent studies have also investigated the potential analgesic benefit of a single perioperative dose of dexamethasone, but the results have been inconsistent. The effect of single-dose, intraoperative, intravenous dexamethasone therapy on post-operative pain and opioid consumption has not yet been studied in patients undergoing cesarean section.
Pain is a significant source of morbidity for many women following cesarean section, and has serious consequences beyond the immediate post-operative period. Patients with poorly-controlled pain may have difficulty with ambulation that can lead to atelectasis, pneumonia, and venous thromboembolism.
Poor maternal pain control may also affect the infant by interfering with bonding and breastfeeding. Reduction of post-operative opioid consumption is desirable because it may also reduce the incidence of opioid-induced side effects such as sedation, constipation, nausea, vomiting and pruritus. Some evidence suggests that the severity of post-operative pain following cesarean section may predict progression to chronic pain, and postpartum depression.
Although 10 to 18% of women who undergo cesarean section will experience chronic pain following surgery, it is difficult to predict those patients who will experience this complication. Recent investigations have shown that patient responses to standardized painful stimuli prior to surgery help predict severity of post-operative pain and possibly progression to chronic pain. This type of information could potentially help to tailor the clinical management of patients at risk for severe and/or chronic post-operative pain to improve outcomes for these patients. Landau and colleagues have described a simple and minimally-invasive method of assessing response to noxious stimuli using a von-Frey filament to obtain a mechanical temporal summation score.
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
- •American Society of Anesthesiology (ASA) class 1, 2 and 3
- •Gestational age > 37 weeks
- •scheduled for elective cesarean delivery
- •spinal or combined spinal epidural anesthesia
- •18 years or older
- •speak English
排除标准
- •BMI > 45 kg/m2
- •Diabetes Mellitus (Type 1, 2 and gestational)
- •mild or severe preeclampsia
- •history of intravenous drug or opioid abuse
- •previous history of chronic pain syndrome
- •history of opioid use in the past week
- •receipt of an antiemetic within 24 h prior to surgery
- •Non-English speaking
研究组 & 干预措施
Dexamethasone
Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
干预措施: Dexamethasone (Drug)
Placebo
Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Morphine Consumption at 24 Hours Post-op
时间窗: 24 hours from admission to Postanesthesia care unit (PACU)
The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine
次要结局
- Pain Scores Between the Groups at 2 Hours.(2 hours from admission to postanesthesia care unit (PACU))
- Time to Administration of First Rescue Analgesic Request Between the Groups.(PACU admission to discharge from PACU an average of 2 hours)
- Cumulative Opioid Consumption at 48 Hours Between the Groups(Admission to PACU through 48 hours)
- Pain Scores Between the Groups at 24 Hours.(24 hours from PACU admission)
- Pain Scores Between the Groups at 48 Hours.(48 hours from PACU Admission)
- Cumulative Opioid Consumption at 24 Hours Between MTS Groups(24 hours from admission to Postanesthesia care unit (PACU))
- Incidence of Chronic Persistent Pain at 8 Weeks(8 weeks from the day of surgery)
- Incidence of Chronic Persistent Pain at 6 Months(6 months from the day of surgery)
- Pain Scores Between MTS Groups(24 hours after PACU admission)
- Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.(From spinal anesthesia placement to end of surgery, approximately 70 minutes)
- Incidence of Intraoperative Pruritus(From spinal anesthesia placement to end of surgery, approximately 70 minutes)
- Incidence of Postoperative Pruritus(48 hours from admission to PACU)
- Need for Intraoperative Analgesic Supplementation(From spinal anesthesia placement to end of surgery, approximately 70 minutes)
- Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics(2, 24 and 48 hours from PACU admission)
- Incidence of Wound Complications(24 hours from PACU admission)
- Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)(Intraoperatively)