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临床试验/NCT03535116
NCT03535116招募中4 期

The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery: A Double Blind Randomized Control Trial

Dr. Chandran Medical Prof Corp1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020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
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Hematoma

研究概览

简要总结

It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for postoperative pain control increases hematoma and bleeding in breast reduction surgery. However, there is no literature that supports this teaching. Ketorolac is used routinely in free flap reconstruction including breast reconstruction as well as many other surgeries including hand surgery without increased risks of hematoma or bleeding. Ketorolac has been shown to give good postoperative pain control. The object of this study is to look at whether ketorolac increases the rate of hematoma/bleeding in breast reduction. If there is no increased risk of hematoma, then ketorolac can be used safely for postoperative pain control with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma rates in a breast reduction are 1-2%.

详细描述

STUDY PROTOCOL

The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery: A Double Blind Randomized Control Trial

Purpose: The purpose of this study to investigate hematoma rates of a single dose of ketorolac given intra-operatively in breast reduction surgery.

Hypothesis: There is no statistically significant difference between the ketorolac and placebo in hematoma rates after intra-operative single use in breast reduction surgery.

PROTOCOL

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

drug vs placebo(saline). Identification is in a sealed envelope. The anesthetist gives the medication without telling the surgeon or the patient what medication is given(patient will be under a general anesthetic). Neither patient or surgeon will know what the patient gets until the follow up period(6 weeks) is completed.

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

  • clinically met criteria for breast reduction(large heavy breasts)

排除标准

  • morbid obesity
  • history of kidney failure
  • allergy to non steroidal anti-inflammatories
  • did not wish or unable to consent to be in the study

研究组 & 干预措施

Patients receiving ketorolac

Experimental

Patient receives 30mg IV ketorolac(single dose) towards the end of the operation.

干预措施: Ketorolac (Drug)

Control

Placebo Comparator

Patients receive saline intravenously towards the end of the operation.

干预措施: Saline (Drug)

结局指标

主要结局

Hematoma

时间窗: 6 weeks

Postoperative hematoma

次要结局

未报告次要终点

研究者

发起方
Dr. Chandran Medical Prof Corp
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geethan Chandran

Assistant Professor

Dr. Chandran Medical Prof Corp

研究点 (1)

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