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临床试验/NCT02927405
NCT02927405撤回4 期

Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

State University of New York - Downstate Medical Center1 个研究点 分布在 1 个国家开始时间: 2020年3月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
Post-operative morphine consumption

研究概览

简要总结

There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.

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
Double (Participant, Care Provider)

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

  • receiving laparoscopic GYN procedure
  • between 18-60

排除标准

  • are already taking gabapentin
  • have diabetic neuropathy
  • have a chronic pain syndrome
  • take opioids at home
  • are pregnant
  • have kidney disease
  • have an allergy to morphine

研究组 & 干预措施

TAP Block plus placebo

Placebo Comparator

Patients will only receive a TAP block procedure and then morphine consumption will be recorded.

干预措施: TAP Block (Procedure)

TAP Block plus gabapentin

Experimental

Patients will receive a TAP block procedure and take pre-operative oral Gabapentin and morphine consumption will me recorded after surgery.

干预措施: Gabapentin (Drug)

TAP Block plus gabapentin

Experimental

Patients will receive a TAP block procedure and take pre-operative oral Gabapentin and morphine consumption will me recorded after surgery.

干预措施: TAP Block (Procedure)

结局指标

主要结局

Post-operative morphine consumption

时间窗: 24 hours after surgery.

Total amount of morphine the patient need to control post-operative pain

次要结局

  • VAS Scores(24 hours after surgery)

研究者

发起方
State University of New York - Downstate Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shantha Ganesan

Director, Pain Medicine

State University of New York - Downstate Medical Center

研究点 (1)

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