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临床试验/NCT04279054
NCT04279054已完成早期 1 期

Decreased Neuraxial Morphine and Adjunctive Peripheral Nerve Blockade to Reduce Severity of Side Effects and Opioid Use After Cesarean Delivery

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2020年9月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
87
试验地点
1
主要终点
Outcome of side effects of intervention: urinary retention

研究概览

简要总结

The purpose of this study is to compare 50mcg to 150mcg morphine in epidural for the goal of decreasing side effects of medication with lower dose in patients who receive a QL block

详细描述

Regional anesthesia has been associated with reduced opioid consumption after surgery. Cesarean delivery is one of the most commonly performed surgeries worldwide and women undergoing cesarean delivery are often young, opioid-naïve, and motivated to recover quickly in an effort to better care for their newborn. However, approximately 1 in 300 opioid naïve women become persistent prescription opioid users following cesarean delivery . Hence, it is important to optimize post-cesarean pain control while limiting exposure to opioids. Currently, standard therapy includes the use of neuraxial morphine (NM) in combination with a multi-modal regime in an effort to limit excessive opioid use after cesarean delivery. The current typical dose of NM that is given prior to cesarean delivery at the investigator's center is 150 mcg. Importantly, NM doses as low as 100 mcg have been shown to provide comparable analgesia while reducing side effects such as itching. The side-effect profile associated with NM includes up to 87% of patients experiencing pruritus and up to 70% experiencing urinary retention. Nausea and vomiting also lead to significant discomfort for a new mother trying to provide acute infant care.

Adjunctive Peripheral Nerve Blockade has recently been introduced to reduce postoperative pain and opioid use. Studies have assessed the usefulness of the transversus abdmoninis plane (TAP) block after cesarean delivery. Another ultrasound-guided injection of local anesthetic in the fascial plane (truncal block) that is available at UAB and within the standard of care for patients undergoing abdominal surgery is the quadratus lumborum (QL) block. Because of its more posterior and caudal location, it is more likely to anesthetize the nerve fibers associated with pain from cesarean delivery.

This study will compare the use of 50mcg to 150mcg morphine for the goal of decreasing side effects of medication with lower dose in all patients who receive a QL block

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

性别
Female
接受健康志愿者

入选标准

  • All women presenting for scheduled cesarean delivery who desire a QL block

排除标准

  • Women with pregnancies complicated by preeclampsia
  • Women with pregnancies complicated by insulin-treated diabetes
  • Women with pregnancies complicated by placental abnormalities
  • Women with pregnancies complicated by a history of opioid use disorder

研究组 & 干预措施

Group A: 150 mcg morphine

Active Comparator

Patients in this group will receive 150mcg of morphine in their neuraxial block

干预措施: Morphine Sulfate 150 mcg (Drug)

Group B: 50 mcg morphine

Experimental

Patients in this group will receive 50mcg of morphine in their neuraxial block

干预措施: Morphine Sulfate 50mcg (Drug)

结局指标

主要结局

Outcome of side effects of intervention: urinary retention

时间窗: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)

Incidence of primary outcome surrogate marker by need for removal of foley catheter as measure for urinary retention

Outcome of side effects of intervention: pruritus

时间窗: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)

Incidence of primary outcome surrogate marker by need for medication for pruritus based on verbal complaints from patient (Medication given: Yes or No)

Outcome of side effects of intervention: nausea

时间窗: One assessment during hospital stay - up to postoperative day 2

Incidence of primary outcome surrogate marker by need for medication for nausea based on verbal complaints from patient (Medication given: Yes or No)

次要结局

  • Neonatal secondary outcomes from intervention(Within first hour of birth)
  • Maternal secondary outcomes from intervention(One measurement during entire hospital stay)

研究者

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

Ayodeji Sanusi

Principal Investigator/ Assistant Professor Maternal Fetal Medicine

University of Alabama at Birmingham

研究点 (1)

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