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临床试验/NCT04439396
NCT04439396已完成1 期

Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use

Carilion Clinic1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2020年6月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
183
试验地点
1
主要终点
Change of post-operative pain: Likert scale

研究概览

简要总结

The purpose of this study is to investigate whether perioperative single-dose administration of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby decreasing post-operative opioid use.

详细描述

The investigators will perform a double blinded, prospective randomized trial of perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures. Patients will be randomized into three groups: group 1 will receive a perioperative dose of ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will be the control and receive a placebo of saline. Patients will be asked to complete a diary or log of their average pain and pain medication use to be turned in at a 2 week follow up visit.

The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the immediate post-operative period, on post-operative day 1, and at their two-week follow up appointment. If patients leave the same day then they will only have two pain score assessments; on day of surgery and at their two-week follow up. Additionally, patients will be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being extreme pain) in morning and evenings using a patient diary for the two week post-op period. The patient's opioid use will be measured by their opioid use during their hospital stay, as well as how many prescription narcotic pills the patient used to manage their pain at home, as documented using the patient diary.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

double blind randomized trial

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient consents to study
  • Adult females needing breast reconstruction or breast reduction (day surgeries)

排除标准

  • Patients with known kidney disease
  • Patient does not consent
  • patients with history of bleeding disorder, peptic ulcer disease, renal disease, blood thinners use, bariatric surgery and any other contraindications of Toradol use
  • patients currently taking aspirin
  • pregnant women (not standard to operate on this population anyway)

研究组 & 干预措施

Control

Placebo Comparator

Saline injection administered during surgical procedure

干预措施: Saline (Other)

Low Dose (15mg) Toradol

Experimental

15mg ketorolac (toradol) administered during surgery

干预措施: Ketorolac Tromethamine (Drug)

High Dose (30mg) Toradol

Experimental

30mg ketorolac (toradol) administered during surgery

干预措施: Ketorolac Tromethamine (Drug)

结局指标

主要结局

Change of post-operative pain: Likert scale

时间窗: 2 week post operation

This will be assessed by using a Likert scale(0=no pain to 10=extreme pain) for pain in the post-operative period before they are discharged. If patients are kept overnight then another pain assessment will be done. Additionally, patients will keep a 2-week diary of average pain in the morning and evening each day until their 2 week follow up visit.

次要结局

  • Complication assessment(2 weeks to 90 days post operation)
  • Change of narcotic use(2 weeks post operation)

研究者

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

James T Thompson

Plastic and Reconstructive Surgeon

Carilion Clinic

研究点 (1)

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