Intrathecal (IT) Hydromorphone for Cesarean Section (C/S): A Dose Finding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S.
研究概览
简要总结
Introduction:
Cesarean section (C/S) is usually performed under spinal with preservative free morphine for pain relief, but the investigators have a severe shortage of this formulation of morphine. Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has been used in spinals for postoperative pain relief and in pain pumps for relief of chronic pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for post C/S pain.
Methods:
This is a randomized double-blind controlled trial utilizing the up-down sequential allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and morphine use per hour will be recorded. Success will be a median morphine usage of less than or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given 10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end after 5 successes.
Objective:
The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S. The secondary objectives are to define the incidence and severity of hydromorphone's side effects and determine the duration of analgesia.
详细描述
SpecificAims Cesarean section (C/S) is usually performed under spinal anesthesia with preservative free morphine added for pain relief, but currently the investigators have a severe shortage of this formulation of morphine. Hydromorphone is a narcotic which has been used in spinals for acute postoperative pain relief and in pain pumps for relief of chronic pain. The investigators hypothesize that a dose between 25 and 200 mcg of IT hydromorphone will provide pain relief for at least 16 hours following C/S, with the need for minimal rescue medication, and therefore may be a reasonable alternative to IT morphine.
Background and Significance Cesarean section is usually performed under spinal anesthesia using bupivacaine. Intrathecal preservative free morphine is often added to decrease postoperative pain for 12-24 hours with only the need for minor rescue medication (a significant intravenous and oral opioid sparing effect). This allows earlier mobilization and interaction with family/infant of these hypercoagulable patients. With the critical shortage of this formulation of morphine, we must find an alternative medication. Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has been used in spinal anesthetics for acute postoperative pain relief and in pain pumps for relief of chronic pain. Currently hydromorphone is not approved for intrathecal administration by the FDA, but pain practitioners commonly prescribe hydromorphone for intrathecal pumps and have so for years. The most recent Poly Analgesic Consensus Conference (PACC) of 2012 included IT hydromorphone as an acceptable opioid for chronic use. Its inclusion for the management of neuropathic and nociceptive pain infers hydromorphone's relative neurologic safety, as it is used in much higher doses than for cesarean section. The investigators reviewed the literature to learn if IT hydromorphone has been used for post C/S pain relief, and if so, at what dose. A retrospective chart review comparing IT hydromorphone to fentanyl after C/S and a case report of IT hydromorphone for a repeat C/S were all the investigators found.3,4 No randomized controlled studies exist.
Our study will find the optimal dose of IT hydromorphone for pain relief following cesarean section as well as delineate the incidence and severity of side effects and how long the drug lasts. This information is critical as no other viable alternatives currently exist to replace IT morphine in this capacity.
Preliminary Studies/Progress Report
The spinal anesthetic including the IT hydromorphone will be performed by a competent anesthesia resident or attending (residents on the obstetric anesthesia service, the principal investigator, or one of the co-investigators). Our C/S rate is about 31% of 2100 deliveries per year and most (>80%) are done under spinal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Females undergoing a primary or repeat elective, scheduled C/S who are not yet in labor will be approached for inclusion in the study
排除标准
- •Patient refusal,
- •Age less than 18 years
- •Onset of labor
- •Current opioid abuse
- •Use of methadone maintenance for previous opioid abuse
- •Allergy to hydromorphone
- •Contraindication to spinal anesthesia
- •Inability to obtain a spinal anesthetic
- •Language other than English or if unable to understand use of a PCA pump will be excluded.
研究组 & 干预措施
IT hydromorphone dose
dose response study
干预措施: intrathecal hydromorphone (IT hydromorphone) (Drug)
结局指标
主要结局
The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S.
时间窗: At 24 hours following the C/S, the patient will rate her pain, degree of nausea, and itching with verbal numeric rating scales.PCA will also be queried for morphine usage.
次要结局
- A secondary objective is to define the incidence and severity of hydromorphone's side effects.(At 4, 8, 12 and 24 hours following the C/S, the patient will rate her degree of nausea, and itching with verbal numeric rating scales.)
- A secondary objective is to determine the duration of analgesia(At 24 hours following the C/S, the PCA will be queried for morphine usage.)