Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- 24hr Post-partum IV Opioid Requirement
研究概览
简要总结
Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing) is to give opioids in the spinal space as part of the medications given for a cesarean delivery.
For many years, the opioid of choice was morphine due to its long anesthetic effect and acceptable side effect profile. A nation-wide disruption in the supply of preservative-free morphine has made it necessary to look for alternatives. Many institutions worldwide have used another opioid, called hydromorphone, in the spinal space for over a decade. This drug has a very good safety and side effect profile and has been used at the investigators' institution for more than a year. Of interest, while a number of different doses of hydromorphone have been used, there have been very few studies to evaluate the best dose for providing good pain relief with minimal side effects. The goal of this study is to find the best dose of spinal hydromorphone for women undergoing cesarean delivery.
详细描述
Intrathecal opioids in have been shown to produce analgesia. Lipid solubility and effect on specific mu opioid receptors in the dorsal horn of the spinal cord primarily determine the analgesic effect of intrathecally injected opioids. Rostral spread of intrathecal opioids causes some of the side effects like pruritus, respiratory depression, nausea and vomiting.
In the investigators' institute, during cesarean delivery under spinal anesthesia is usually performed with 1.6-1.8 ml of 0.75% bupivacaine with dextrose (hyperbaric solution) with 10-20mcg of fentanyl. Preservative free intrathecal (IT) morphine100 to 200 mcg is injected at the time of initiation of spinal block for postoperative pain relief. Multiple studies have shown excellent postoperative pain relief following cesarean delivery up to 18hrs with this dosing regimen.
However, there has been a national shortage of preservative free morphine since August 2012. Based on the pharmacokinetic and pharmacodynamic profile, intrathecal (IT) preservative free hydromorphone 100 mcg has been used as a substitute. Anecdotal experience during the past 8 months suggest that patients have comparable post partum pain relief, with a similar side-effect profile to IT morphine.
There is no published data on the optimal dose of IT hydromorphone for post cesarean analgesia. There are case reports and retrospective case study of use of 100mcg IT hydromorphone. One randomized controlled trial for knee arthroscopy used 2.5-5-10 mcg of IT hydromorphone for postoperative analgesia.
Hence it is important to determine the optimal dose of IT hydromorphone for post operative pain management following cesarean delivery in terms of analgesic efficacy, incidence of side effects and the need for treatment interventions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy at-term parturients undergoing elective cesarean delivery under spinal anesthesia
排除标准
- •Emergency cesarean delivery
- •Respiratory disease
- •significant comorbidities: preeclampsia, insulin-dependent diabetes mellitus
- •obstructive sleep apnea
- •body mass index > 35kg/m2
- •documented intolerance or allergy to systemic or neuraxial opioids
- •patient with a history of chronic opioid or current use of opioids
研究组 & 干预措施
Hydromorphone 25mcg
The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
干预措施: Hydromorphone 25mcg (Drug)
Hydromorphone 25mcg
The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
干预措施: spinal anesthesia (Drug)
Hydromorphone 50mcg
The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
干预措施: Hydromorphone 50mcg (Drug)
Hydromorphone 50mcg
The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
干预措施: spinal anesthesia (Drug)
Hydromorphone 100mcg
The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
干预措施: Hydromorphone 100mcg (Drug)
Hydromorphone 100mcg
The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
干预措施: spinal anesthesia (Drug)
结局指标
主要结局
24hr Post-partum IV Opioid Requirement
时间窗: 24hrs after administration of intrathecal hydromorphone
Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.
次要结局
- Oxygen Saturation, Need for Supplemental Oxygen(24hrs post administration of IT hydromorphone)
- Patients With Nausea and Vomiting Requiring Rescue Medication(24hrs post administration of IT hydromorphone)
- Number of Patients With Hypothermia (Body Temperature < 95F/35C)(24hrs post administration of IT hydromorphone)
- Number of Patients With Visual Disturbances(24hrs post administration of IT hydromorphone)
- Number of Patients With Pruritus(24hrs post administration of IT hydromorphone)
- Intraoperative Vasopressor Use: Ephedrine Equivalents(Intraoperatively (at time of operation))
- Intraoperative Vasopressor Use: Phenylephrine Equivalents(Intraoperatively (at time of operation))
研究者
Dirk Varelmann, MD
Instructor of Anaesthesiology
Brigham and Women's Hospital