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临床试验/NCT03394001
NCT03394001Unknown4 期

Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy: a Prospective, Randomized, Double-blind Study.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
Rescue analgesia time

研究概览

简要总结

The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.

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
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status I and II
  • Planned for elective TAH with a Pfannenstiel incision

排除标准

  • Patients with the following criteria will be excluded from the study;
  • ASA physical status more than II
  • Body mass index (BMI)>35 kg/m2
  • Previous abdominal surgeries
  • Malignancy
  • Individuals with chronic pain
  • A history of severe systemic disease
  • A pre-existing neurological or psychiatric illness
  • Known to be addict on alcohol or drugs
  • Known allergy to the study drugs

研究组 & 干预措施

Lidocaine Hydrochloride

Active Comparator

Wound infiltration with Lidocaine

干预措施: Wound infiltration (Procedure)

Lidocaine Hydrochloride

Active Comparator

Wound infiltration with Lidocaine

干预措施: Lidocaine Hydrochloride (Drug)

Ketorolac tromethamine

Active Comparator

Wound infiltration with Ketorolac

干预措施: Wound infiltration (Procedure)

Ketorolac tromethamine

Active Comparator

Wound infiltration with Ketorolac

干预措施: Ketorolac tromethamine (Drug)

结局指标

主要结局

Rescue analgesia time

时间窗: First 24 hours postoperatively

Time for first analgesia requirement

次要结局

  • The total analgesic consumption(First 24 hours postoperatively)
  • Patient's pain score(First 24 hours postoperatively)

研究者

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

Marwa Mostafa Mohamed Ali Mowafi

Lecturer

Ain Shams University

研究点 (1)

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