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临床试验/NCT04360135
NCT04360135撤回2 期

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial

Montefiore Medical Center1 个研究点 分布在 1 个国家开始时间: 2020年5月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Post-operative opioid use

研究概览

简要总结

This study is investigating whether administration of acetaminophen the day before surgery improves post operative pain following minimally invasive hysterectomy. Patients will receive either acetaminophen or placebo to take twice per day the day prior to their scheduled surgery. The morning of surgery all participants will receive oral acetaminophen at least 30 minutes prior to surgery. The investigators will examine whether there is a difference in post operative pain between the two groups.

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 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing minimally invasive hysterectomy for benign indications

排除标准

  • acetaminophen allergy
  • liver disease
  • kidney disease
  • consume >3 alcoholic beverages per day
  • weigh <50 kilograms
  • report daily opiate use
  • contraindication to acetaminophen
  • used acetaminophen within 24 hours of surgery
  • undergoing a concomitant pelvic reconstructive procedure

研究组 & 干预措施

Preemptive acetominophen

Experimental

Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively

干预措施: Acetaminophen (Drug)

Standard of care

Placebo Comparator

Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively

干预措施: Placebo (Drug)

结局指标

主要结局

Post-operative opioid use

时间窗: 4 hours

The total amount of opiate consumption in the immediate postoperative period will be recorded. Per standard protocol, patient's will be ordered for pain medication to receive on an as needed basis. The amount of both oral and IV opioids consumed by the patient will be converted to total morphine equivalents. As such, post operative opioid use will be used as a proxy for degree of post operative pain.

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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