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临床试验/NCT01866917
NCT01866917终止1 期

Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
35
试验地点
1
主要终点
Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

研究概览

简要总结

Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures

排除标准

  • Conversions, non-obese women

研究组 & 干预措施

TAP

Experimental

Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe

干预措施: Ropivacaine 0.5% 20cc injectate bilaterally (Drug)

Saline

Placebo Comparator

Patients will receive Normal saline 20cc injectate from a study labeled syringe

干预措施: Placebo (Drug)

结局指标

主要结局

Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

时间窗: 0, 1, and 2 hours

Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable

Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

时间窗: 4hrs, 8hrs, 12hrs, and 24hrs.

Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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