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临床试验/NCT03103100
NCT03103100已完成3 期

Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年10月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
75
试验地点
1
主要终点
Time to Achieve an Adequate Epidural Level for Labor Analgesia

研究概览

简要总结

This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.

详细描述

The most common and effective method for controlling labor pains is a local anesthetic (LA) infusion through a lumbar epidural. To achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10 dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering LA through the epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. The ideal LA to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects.

Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these LA can be administered safely with very little concern of major adverse effects associated with LA toxicity. Given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the LA combination offers any distinct advantage over the individual LA. The investigators intend to determine the time it takes to achieve an adequate level (T10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal LA solution to activate a labor epidural. With the results from this study, the investigators hope to recommend a LA solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study

排除标准

  • allergy to the drug or drug class
  • preexisting neuropathy
  • history of back pain prior to pregnancy or history of back surgery
  • history of chronic opioid use
  • history of hypertension or hypertensive disorders of pregnancy
  • congenital or acquired cardiac disease
  • contraindication to epidural placement (patient refusal, severe coagulopathy, infection at site of epidural needle insertion, severe hypovolemia)

研究组 & 干预措施

0.25% Bupivacaine

Active Comparator

Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine

干预措施: 0.25% Bupivacaine (Drug)

1% Lidocaine

Active Comparator

Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine

干预措施: 1% Lidocaine (Drug)

Bupivacaine plus Lidocaine

Active Comparator

Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.

干预措施: Bupivacaine plus Lidocaine (Drug)

结局指标

主要结局

Time to Achieve an Adequate Epidural Level for Labor Analgesia

时间窗: Baseline to 1 hour

time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.

次要结局

  • Number of Patients Who Achieve Adequate Analgesia(Baseline to 1 hour)
  • Number of Patients Who Experienced of Maternal Hypotension(Baseline to 1 hour)
  • Degree of Motor Block(Baseline to 1 hour)

研究者

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

Mark Powell

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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