The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery: A Double Blind Randomized Control Trial
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
- 否
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
Patient receives 30mg IV ketorolac(single dose) towards the end of the operation.
干预措施: Ketorolac (Drug)
Control
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
Geethan Chandran
Assistant Professor
Dr. Chandran Medical Prof Corp
