"Preoperative Gabapentin and Its Effects on Postoperative Analgesia in Patients Undergoing Cosmetic Breast Surgery"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
The goal of this clinical trial is to compare postoperative pain and opioid consumption in patients who undergo cosmetic breast surgery and are treated preoperatively with gabapentin. The main questions to answer are the amount of postoperative pain on a scale of 0-10 and amount of opioids consumed postoperatively. Participants will be randomized into two groups: treatment vs no treatment. Treatment group will receive 600mg of gabapentin preopreatively. Researchers will compare treatment vs no treatment group to determine the effects of preoperative gabapentin on postoperative pain management and opioid consumption.
详细描述
HYPOTHESIS We hypothesize that a single dose of preoperative gabapentin will improve postoperative pain scores and decrease postoperative opioid requirements in our study population. This will be tested by administering a preoperative dose of 600mg of gabapentin and measuring pain scores and amount of opioid consumption during the postoperative period. The study will compare two groups. Participants will be randomly assigned to one of the two groups and will consist of a treatment group and a control group. We will measure pain scores in a simple 0-10 scale and amount of opioid consumption during the first 7 days after discharge and compare them with patients who did not receive preoperative gabapentin. Our aims are to determine if gabapentin improves postoperative analgesia and reduces postoperative opioid requirements in a population undergoing cosmetic breast surgery
METHODOLOGY AND STUDY DESIGN
This study will be a randomized control trial. Participants will be randomized and divided into treatment versus no treatment group. Treatment group will be administered a dose of 600mg of gabapentin within 2 hours of surgery. Amount of postoperative opioids will be measured for 7 days, post op pain scores will be measured twice daily for 7 days. This information will be collected via postoperative questionnaires.
STUDY SUBJECTS Participants will be adult, non pregnant patients older than 18 years undergoing cosmetic breast surgery at either Hospital Oncologico Isaac Gonzalez Martinez or Hospital UPR Federico Trilla. Participants will be selected during the initial clinic visit, there will be no specific recruiting strategies. Excluded populations include minors 18 years old or less as well as pregnant females due to health concerns. Participants will be explained in detail the goal and objectives of study along with risks vs benefits. The following HIPAA identifiers will be excluded: Geographical elements, fax numbers, social security numbers, health insurance beneficiary numbers, vehicle identifiers, digital identifiers, digital attributes, IP addresses, biometric elements and full face photographic images.
VARIABLES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults 18 to 65 y/o without chronic gabapentin and/or opioid use
排除标准
- •minors less than 18 y/o, adults older than 65 y/o, chronic users of gabapentin and/or opioids, pregnant females
研究组 & 干预措施
Treatment
Patient will be treated with preoperative gabapentin
干预措施: Gabapentin 600Mg Tab (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: Days 1-7 postoperatively
Amount of postoperative standardized opioid doses
Postoperative pain
时间窗: Days 1-7 postoperatively
Amount of postoperative pain on a scale from 1-10
次要结局
未报告次要终点
研究者
Miguel Serpa Irizarry
MD
University of Puerto Rico
