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临床试验/NCT03110003
NCT03110003已完成3 期

Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年6月27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
45
试验地点
1
主要终点
Time Until PACU Discharge in Minutes

研究概览

简要总结

In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.

详细描述

Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.

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
None

入排标准

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

入选标准

  • Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.

排除标准

  • coagulopathy
  • platelets <80,000
  • allergy to local anesthetic or fentanyl
  • previous spinal surgery
  • spinal or intracranial mass
  • history of lower extremity weakness

研究组 & 干预措施

10 mg Bupivacaine

Active Comparator

Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.

干预措施: 10 mg Bupivacaine (Drug)

5 mg Bupivacaine

Active Comparator

Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

干预措施: 5 mg Bupivacaine (Drug)

结局指标

主要结局

Time Until PACU Discharge in Minutes

时间窗: Baseline up to 48 hrs postoperatively

Time from entrance into the PACU until PACU discharge criteria met

次要结局

  • Patient Satisfaction as Determined by a Likert-type Scale(At 6 hrs postoperatively)
  • Peak Block Height(Baseline up to 3 hours)
  • Degree of Peak Motor Blockade by Modified Bromage Scale(Baseline up to 3 hours)
  • Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0(Baseline up to 6 hours)
  • Quality of Block as Determined by Subjective Pain Assessment(Baseline up to 6 hours)

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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