Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Opioid Consumption in the 0-48 Hour Study Periods.
研究概览
简要总结
The ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. This study hopes to determine if patient's involvement in analgesic drug/dosage selection can optimize pain relief while minimizing related side effects. This could result in a more patient-centered care model and individualized perioperative analgesic treatment protocols based on patient's preferences, needs and expectations.
详细描述
This randomized, controlled study will include a simple, preoperative questionnaire to obtain baseline demographic and obstetric data; and complete questions (that have previously been shown to be predictive of postoperative pain) from which we will determine their expected and target postoperative pain scores. These questionnaires should take less than 3-4 minutes to complete.
The subject will then be randomized into "choice" and "no choice" groups. The randomization for choice vs. no choice will be at a 1:3 ratio i.e. 1 woman will get no choice and 3 will get a choice for their analgesic protocol. All women will receive the same medications for intraoperative anesthetic management -- only the postoperative pain medications will be altered.
The no choice group will receive the current standard analgesic protocol: medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h.
The group with the choice will be offered 3 different protocols:
- low dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 2 medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 3. high dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h, as well as gabapentin po one time within 1 hr of delivery.
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, 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
- 否
入选标准
- •Women age 18-50
- •Singleton gestation
- •Not in active labor
- •Scheduled for their 1st, 2nd, or 3rd elective Cesarean
- •Cesarean deliveries under spinal or combined spinal epidural anesthesia (with no additional epidural doses administered)
排除标准
- •History of chronic pain, anxiety, or depression
- •Unable to understand the concept of Verbal Numerical Pain Scale at the time of informed consent
- •Chronic consumption of opiates, antidepressants or anticonvulsants
- •Intake of opioids, NSAIDS or acetaminophen 48hrs prior to the psychophysical test
- •Preeclampsia (with any severe features)
- •Diabetes (not controlled with diet and needing drugs)
- •Preterm delivery (<35 weeks gestation)
研究组 & 干预措施
Choice: low protocol
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Acetaminophen (Drug)
No choice
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: No choice given (Other)
No choice
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Ibuprofen (Drug)
No choice
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Acetaminophen (Drug)
No choice
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Morphine (med) (Drug)
Choice: low protocol
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Choice given (Other)
Choice: low protocol
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Ibuprofen (Drug)
Choice: low protocol
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Morphine (low) (Drug)
Choice: medium protocol
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Choice given (Other)
Choice: medium protocol
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Ibuprofen (Drug)
Choice: medium protocol
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Acetaminophen (Drug)
Choice: medium protocol
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
干预措施: Morphine (med) (Drug)
Choice: high protocol
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
干预措施: Choice given (Other)
Choice: high protocol
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
干预措施: Ibuprofen (Drug)
Choice: high protocol
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
干预措施: Acetaminophen (Drug)
Choice: high protocol
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
干预措施: Gabapentin (Drug)
Choice: high protocol
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
干预措施: Morphine (high) (Drug)
结局指标
主要结局
Opioid Consumption in the 0-48 Hour Study Periods.
时间窗: 0-24 and 24-48 hour postoperative periods
Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Pain Scores
时间窗: 3, 6, 12, 24, 36 and 48 hours after delivery
Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.
次要结局
- Count of Participants Who Need Opioid Use(0-24 and 24-48 hours after delivery)
- Count of Participants With Presence of Pruritus(0-24 and 24-48 hours after delivery)
- Pruritus Score at 24 and 48 After Delivery(24 and 48 hours following delivery)
- Count of Participants Who Need Medical Treatment of Pruritus(0-24 and 24-48 hours after delivery)
- Counts of Participants With Presence of Nausea(0-48 hours after delivery)
- Nausea Score Score at 24 and 48 After Delivery(0-24 and 24-48 hours after delivery)
- Counts of Participants Who Need Medical Treatment for Nausea(0-24 and 24-48 hours after delivery)
- Average Number of Vomiting Episodes After Delivery(0-24 and 24-48 hours after delivery)
- Time to Discharge(Delivery through discharge (average 4 days))
- Patient Overall Satisfaction With Postoperative Analgesia(24 and 48 hours after delivery)
研究者
Brendan Carvalho
Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine
Stanford University