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临床试验/NCT02036983
NCT02036983已完成不适用

Comparison of an Ultrasound Guided Bilateral Transversus Abdominis Plane Block With Dexamethasone and Preperitoneal Instillation of Local Anesthetic With Dexamethasone to a Standard Anesthetic Technique for Analgesic Efficacy and Patient Satisfaction Following a Total Extraperitoneal Bilateral Inguinal Hernia Repair: A Prospective Randomized Single Blinded Study

Indiana University School of Medicine2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair

研究概览

简要总结

Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under direct visualization will be compared it to a standard anesthetic technique (control) following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are hypothesizing that the bilateral TAP block and preperitoneal instillation of local anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction and post-operative pain control when compared to a standard anesthetic technique (no regional technique).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 yrs of age
  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Scheduled for outpatient TEP bilateral inguinal hernia repair

排除标准

  • Patients refusal to participate
  • inability to give consent
  • drug allergies to medications used in study
  • pregnancy
  • bleeding diathesis
  • conversion to an open procedure
  • any subject whose anatomy, or surgical procedure, in the opinion of the investigator might preclude the potential successful performance of a TAP block
  • any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block

研究组 & 干预措施

Control Group

Placebo Comparator

Standard anesthetic technique

干预措施: Opioid IV medications (Control) (Procedure)

Ultrasound guided bilateral TAP block

Active Comparator

Ultrasound guided TAP Block with local anesthetic and dexamethasone.

干预措施: Transversus abdominis plane block (TAP BLOCK) (Procedure)

Instillation of surgical site with local anesthestic.

Active Comparator

Instillation of surgical site under direct visualization with local anesthetics and dexamethasone.

干预措施: Instillation of surgical site with local anesthetic. (Procedure)

结局指标

主要结局

Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair

时间窗: Post-operatively (Day 1)

Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery.

次要结局

  • Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair(Post-operatively (day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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