A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Postsurgical Pain
研究概览
简要总结
For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. The investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.
详细描述
Included in the study will be all healthy (ASA I or II) woman having elective Cesarean sections who are candidates for regional anesthesia. Exclusion criteria include morbid obesity (BMI > 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics.
All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section. The patients will be visited twice a day postoperatively for two days. The epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. Additional analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for breakthrough pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients having an elective Cesarean section
- •Healthy women (ASA I or II)
- •Regional anesthesia candidates
排除标准
- •Morbid obesity (BMI>40)
- •Sleep apnea
- •Age under 18
- •Intolerance or addiction to opioids
研究组 & 干预措施
Preservative free morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
干预措施: Preservative free morphine (Drug)
Fentanyl infusion
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Postsurgical Pain
时间窗: At 8, 24 36 and 48 hours after the Cesarean section
Participants will be asked to rate their pain on a 10 point Numerical Rating Pain Scale, where zero is no pain and ten is the most intense pain possible.
次要结局
- Number of Participants Who Responded Yes to Having Nausea or Vomiting(At 8, 24, 36 and 48 hours after the Cesarean section)
- Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention(At 8, 24, 36 and 48 hours after Cesarean section)
- Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression(At 8, 24, 36 and 48 hours after the Cesarean section)
- Patient Satisfaction(At 8, 24, 48 and 36 hours after Cesarean section)
- Number of Participants Who Responded Yes to Having Back Pain(At 8, 24, 36 and 48 hours after the Cesarean section)
- Number of Participants Who Responded Yes to Having Pruritis(At 8, 24, 36 and 48 hours after Cesarean section)
研究者
Dr. Evan Goodman, MD
Anesthesiologist
Goodman, Evan, M.D.