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临床试验/NCT05069012
NCT05069012已完成4 期

Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
72
试验地点
1
主要终点
Duration of Pain Relief

研究概览

简要总结

This is a randomized double blinded non-inferiority study comparing the duration of pain relief when patients receive one of three doses of spinal morphine. Enrolled patients will be randomly assigned to receive either 50 mcg, 150 mcg, or 250 mcg. All patients will receive standardized postoperative care, including multimodal analgesia. The primary outcome will be the time until the patient requests additional opioid pain medications.

详细描述

Prospective, randomized, double-blind, controlled trial, with a non-inferiority design. Patients will be randomly assigned to receive either intrathecal morphine 50 mcg, 150 mcg, or 250 mcg based on a pre-assigned randomization sequence. This medication will be administered as part of their spinal anesthesia for cesarean delivery. the patient, clinician who administers the spinal anesthesia, and investigator who follows the patient will all be blinded to the dose of medication.

All patients will receive standard of care for cesarean delivery and routine nursing care. This includes: preoperative intravenous catheter placement with preoperative IV fluid, standard American Society of Anesthesiologists monitoring, and neuraxial anesthesia placement (either spinal or combined spinal epidural) in sterile fashion. Each patient will receive standard cesarean induction dose of intrathecal medication consisting of 1.5ml of 0.75% hyperbaric bupivacaine, fentanyl 25 mcg. At end of surgery, all patients will receive standard dose of ketorolac 30 mg IV and acetaminophen 1 gm IV and continue with redosing every 6 and 8 hours (respectively) for 24 hours. On arrival to PACU, all patients will receive standard nursing care with standard monitoring of side effects. On discharge from PACU, patients will be transferred to postpartum floor and receive standard nursing care and monitoring.

Over the following 24 hours, the patient will receive all standard post-cesarean care. For treatment of breakthrough pain, medications will provided be per standard care: oxycodone 5-10 mg PO every four hours PRN for pain. If the patient is not comfortable after receiving oral oxycodone they will be assessed by an anesthesia provider for either regional nerve block or additional opioids, as a one-time dose or by patient controlled analgesia (PCA).

For treatment for side effects, medications will provided be per standard care: ondansetron 4mg IV as first-line for nausea/vomiting, promethazine 6.25 mg IV or Haloperidol 0.5-1mg IV for refractory nausea/vomiting. Naloxone 0.04 mg IV for refractory pruritus.

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)

盲法说明

Randomization maintained in the research pharmacy. Blinded syringe delivered to the investigator for the study.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy women (ASA 2)
  • Between 18 and 45 years old
  • Singleton term pregnancies
  • Planned neuraxial anesthesia

排除标准

  • Refusal to participate
  • Known allergy or contraindication to any medication used in the study
  • Significant medical or obstetrical disease (ASA ≥ 3)
  • Opioid use disorder
  • Chronic pain syndrome
  • Daily or near daily opioid use within last 3 weeks.
  • Patient receiving a Monoamine oxidase inhibitors (MOAi)

研究组 & 干预措施

50 micrograms

Active Comparator

Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery

干预措施: Morphine Sulfate (Drug)

150 micrograms

Active Comparator

Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery

干预措施: Morphine Sulfate (Drug)

250 micrograms

Active Comparator

Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery

干预措施: Morphine Sulfate (Drug)

结局指标

主要结局

Duration of Pain Relief

时间窗: 72 hours after delivery

Time to patient request for first dose of oral rescue pain medicine

次要结局

  • Nausea(24 hours after delivery)
  • Pain Scores(24 hours after delivery)
  • Quality of Recovery(24 hours after delivery)
  • Pruritus(24 hours after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Hess

Associate Professor

Beth Israel Deaconess Medical Center

研究点 (1)

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