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临床试验/NCT01964781
NCT01964781已完成4 期

The Effect of Topical Administration of Tranexamic Acid, Adrenaline and Bupivacain on Postoperative Bleeding and Pain in Patients Undergoing Breast Surgery. A Four-armed Placebo-controlled Double Blinded Randomized Study

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Amount of blood on drains postoperatively

研究概览

简要总结

After surgical procedures, interventions to reduce postoperative pain and bleeding are of great importance. In this study, the effect will be investigated of smearing common drugs, which are designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. Although beneficial effects of such an easy and low-cost intervention would be expected, the investigators have found no previous reports on blinded and controlled studies.

详细描述

The drugs to be studied on whether they reduce bleeding are adrenaline (constricts blood vessels) and tranexamic acid (TXA) (prevents bloodclots from dissolving). The drug studied to what extent it reduces pain will be bupivacaine, a common local anaesthetic. Patients undergoing bilateral symmetric breast surgery or single sided mastectomies are candidates for enrollment in the study. The bilateral patients will have two identical procedures and hence two identical wounds in the same patient. This enables the investigators to use one side as control and hence design our study arms as prospective and placebo-controlled. The patients undergoing a one-sided procedure will need to be compared to similar patients, but as wounds will be of different sizes and in different people, larger groups are needed to find significant differences between treatment and controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
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

  • Patients undergoing unilateral simple mastectomy
  • patients undergoing bilateral symmetric breast surgery

排除标准

  • pregnancy
  • A history of former thromboembolic events (to receive TXA)
  • cardiovascular disease (to receive adrenaline)

研究组 & 干预措施

topical tranexamic acid

Experimental

tranexamic acid to be smeared on surgical wounds before closure

干预措施: Tranexamic Acid (Drug)

topical adrenaline

Experimental

adrenaline solution to be smeared on surgical wounds before closure

干预措施: Adrenaline (Drug)

topical bupivacaine

Experimental

bupivacaine to be smeared on surgical wounds before closure

干预措施: Bupivacaine (Drug)

topical adrenaline plus tranexamic acid

Experimental

tranexamic acid and adrenaline to be smeared on surgical wounds before closure

干预措施: Tranexamic Acid (Drug)

topical adrenaline plus tranexamic acid

Experimental

tranexamic acid and adrenaline to be smeared on surgical wounds before closure

干预措施: Adrenaline (Drug)

placebo control

Placebo Comparator

saline to be smeared on surgical wounds before closure

干预措施: saline (Drug)

tranexamic acid and placebo control

Placebo Comparator

tranexamic acid and saline to be smeared on surgical wounds before closure

干预措施: tranexamic acid plus saline (Drug)

结局指标

主要结局

Amount of blood on drains postoperatively

时间窗: 24 hours postoperatively

Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml on the control after 24 hours.

Amount of pain in operated breast

时间窗: Measured 24 hours postoperatively

Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively

次要结局

未报告次要终点

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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