Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS) (0-10)
研究概览
简要总结
The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are:
Does the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain.
Participants will be asked to:
- Drink a pre-surgery carbohydrate drink two hours before your surgery.
- Take a pre-surgery dose of Tylenol by mouth.
- Take a pre-surgery dose of Gabapentin by mouth.
- The surgeon will administer a local numbing medication at the surgery site by injection during the surgery.
- Begin walking with assistance about 12 hours after your surgery.
- Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •over 18 years of age
- •receiving a kidney transplant from a living donor.
排除标准
- •delayed gastric emptying
- •severe type I diabetes
- •allergy to interventional medications
- •pregnancy (this is a normal exclusion for kidney recipients)
研究组 & 干预措施
Enhanced Recovery Protocol
This group will receive the following:
50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery
干预措施: Bupivacaine (Drug)
Enhanced Recovery Protocol
This group will receive the following:
50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery
干预措施: pre-operative carbohydrate drink (Dietary Supplement)
Enhanced Recovery Protocol
This group will receive the following:
50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery
干预措施: Ambulation (Other)
Control group
This group is a retrospective review of 30 patients who have undergone a live donor kidney transplant during 1/1/2022-12/31/2024 will be selected and undergo a retrospective chart review for the same data collection points.
Enhanced Recovery Protocol
This group will receive the following:
50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery
干预措施: Gabapentin (Drug)
Enhanced Recovery Protocol
This group will receive the following:
50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) (0-10)
时间窗: From enrollment to the end of treatment at 30 days
Patient reported pain on a scale from 0 (no pain) to 10 (the worst possible pain)
Narcotic Use
时间窗: From enrollment to the end of treatment at 30 days
milligram morphine equivalents (MME)
次要结局
- Adverse Events(From enrollment to the end of treatment at 30 days)
- Length of Stay(From enrollment to the end of treatment at 30 days)
- Hospital readmission(From enrollment to the end of treatment at 30 days)