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临床试验/NCT01074229
NCT01074229已完成不适用

The Effect of Pre-operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Randomized, Blinded Study

Northwestern University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年3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
75
试验地点
1
主要终点
QoR40 on the Day After Surgery

研究概览

简要总结

The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery.

Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics.

Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%.

This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.

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
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-64 years
  • Surgery: Laparoscopic Hysterectomy surgery
  • ASA status: I and II
  • Fluent in English

排除标准

  • History of allergy to local anesthetics
  • History of chronic opioid use
  • Pregnant patients
  • BMI greater than 30
  • Drop-out criteria:
  • Patient or surgeon request
  • Complications related to the procedure

研究组 & 干预措施

Placebo

Placebo Comparator

sterile normal saline as placebo

干预措施: Placebo (Drug)

Drug .5% Ropivacaine

Active Comparator

Instillation of 20 cc of 0.5% ropivacaine

干预措施: Drug .5% Ropivacaine (Drug)

20 cc of 0.25% ropivacaine

Active Comparator

Instillation of 20 cc of 0.25% ropivacaine

干预措施: 20 cc of 0.25% ropivacaine (Drug)

结局指标

主要结局

QoR40 on the Day After Surgery

时间窗: 1 day

QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.

次要结局

  • 24 Total Morphine Consumption(1 day)

研究者

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

Gildasio De Oliveira

Gildasio De Oliveira, M.D. Principal Investigator

Northwestern University

研究点 (1)

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