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临床试验/NCT01015807
NCT01015807已完成不适用

Transversus Abdominis Plane (TAP) Block for Cesarean Section

University of Washington2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups

研究概览

简要总结

The purpose of this study is to determine whether a transversus abdominis plane (TAP) block with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-CS chronic pain.

详细描述

Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3 million cesarean deliveries per year in the US, this is bound to create a significant health problem. One way to address this health burden is to refine techniques that may help control the pain women experience after CS and ultimately reduce the potential to develop chronic pain.

The purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (TAP) block to reduce the amount of hyperalgesia women develop around their incision after CS. Measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain. Since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help diminish the incidence of chronic pain after CS. In addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery.

The primary aim of this study is to evaluate the benefits of two different solutions injected by TAP block technique on postoperative peri-incisional hyperalgesia.

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
Double (Participant, Care Provider)

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

  • non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia
  • English speaking (UW Site) or Portuguese speaking (Brazil site)
  • aged between 18 and 45 years
  • BMI < 40
  • ASA physical status class I or II

排除标准

  • laboring women undergoing a non-scheduled cesarean delivery
  • non-English speaking (UW Site) or non-Portuguese speaking (Brazil site)
  • previous spinal surgery
  • contraindications for neuraxial anesthesia
  • allergy to local anesthetic, ultrasound conduction gel, or Clonidine
  • history of chronic pain
  • inability to receive intraoperative Toradol

研究组 & 干预措施

Placebo

Placebo Comparator

Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo

干预措施: Bupivacaine Placebo (Drug)

Placebo

Placebo Comparator

Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo

干预措施: Clonidine Placebo (Drug)

TAP (Bupi)

Active Comparator

2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo

干预措施: Clonidine Placebo (Drug)

TAP (Bupi)

Active Comparator

2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo

干预措施: Bupivacaine (Drug)

Clo-TAP (Bupi + Clon)

Active Comparator

2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine

干预措施: Bupivacaine (Drug)

Clo-TAP (Bupi + Clon)

Active Comparator

2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine

干预措施: Clonidine (Drug)

结局指标

主要结局

Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups

时间窗: 48hrs after CS

Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.

次要结局

未报告次要终点

研究者

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

Laurent Bollag

Assistant Professor, Department of Anesthesiology and Pain Medicine

University of Washington

研究点 (2)

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