A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Verbal Pain Score With Movement
研究概览
简要总结
The purpose of this study is to determine if epidural meperidine administered by patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled bolus.
详细描述
The objective of this study is to compare the efficacy, patient satisfaction, and incidence of side effects of meperidine patient-controlled epidural analgesia (PCEA) with and without a basal infusion for post-cesarean section analgesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •non-English speaking
- •mentally disabled
- •allergy to meperidine
- •seizure disorder
- •renal impairment defined as a serum creatinine >0.8 mg/dL or patients who give a history of renal impairment
- •fever greater than 101
- •patients receiving low molecular weight heparin at any dose or unfractionated heparin at doses greater than 5000 u subcutaneous twice daily
- •pre-eclampsia requiring magnesium due to post-partum room assignment
- •obstructive sleep apnea due to post-partum room assignment
- •post-partum hemorrhage due to post-partum room assignment
研究组 & 干预措施
Meperidine PCEA
Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.
干预措施: Meperidine (Drug)
Meperidine PCEA with basal
Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg
干预措施: Meperidine (Drug)
结局指标
主要结局
Verbal Pain Score With Movement
时间窗: 36-48 hours post-op (until epidural is stopped)
Verbal Pain Score on a 0-10 scale is recorded by the nurse at 0, 4, 8, 12, 16, 20, 24, 28, 32, 36,40, 44, and 48 hours after transfer to the post-partum floor. On this scale, 0 represents no pain at all and 10 represents the worst pain imaginable. Because we were relying on nurses to capture this data in the course of normal patient care, scores within 1 hour before or after the goal time were accepted. For each patient, the average of all pain scores was taken and this was considered to be the average pain score while the epidural meperidine was being given.
次要结局
- Nausea and Vomiting(36-48 hours post-op (until epidural is stopped))
- Pruritus(36-48 hours post-op (until the epidural is stopped))
- Dysphoria(36-48 hours post-op (until epidural is stopped))
- Inadequate Analgesia(36-48 hours post-op (until the epidural is stopped))
- Adverse Outcomes(36-48 hours post-op (until the epidural is stopped))
- Total Drug Dose(48 hours post-op or when the epidural is stopped)
- American Pain Society Patient Outcome Questionnaire #1(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #2(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #3(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #4a(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #4b(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #4c(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #4d(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #5a(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #5b(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #5c(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #5d(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #6a(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #6b(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #6c(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #6d(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #7(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #8(Survey day epidural stopped)
- American Pain Society Patient Outcome Questionnaire #9(Survey day epidural stopped)
研究者
Christy L Morgan, MD
Obstetric Anesthesiologist
Mercy Research