Enhanced Recovery After Surgery in Living Donor Kidney Transplant Donors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- post operative opioid consumption
研究概览
简要总结
Enhanced recovery after surgery (ERAS) pathways are designed to optimize perioperative management, improving patient outcomes and satisfaction through multimodal techniques. Living kidney transplant donors are typically healthy individuals who undergo laparoscopic nephrectomy. The most significant hindrance to discharge to return to activities of daily living is frequently return of bowel function and postoperative pain.
Through a randomized controlled trial design, we will evaluate the effectiveness of implementing an ERAS pathway. We hypothesize that preoperative patient optimization through exercise, carbohydrate loading, and counseling on expectations, in addition to multimodal pain management strategies which limit opioids would allow faster recovery, early bowel function, decreased postoperative pain, increased patient satisfaction and shorter length of stay.
The study population will include a total of 42 patients (age 18-80) who are American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3, undergoing living donor nephrectomy. Our primary outcome measures will be postoperative opioid consumption. Secondary outcome measures are: postoperative pain score, time to return of bowel function, ambulation, first oral intake postoperatively, and patient satisfaction scores. Other objectives include reducing readmissions, shorter hospital length of stay and decreased operative complications, including nausea, vomiting and wound infection.
详细描述
ERAS pathways have been widely used in multiple surgical disciplines leading to improvements in perioperative care. The goal of the pathways is to decrease postoperative opioid consumption, improve pain scores, decrease length of hospital stay, lower morbidity, and increase patient satisfaction. Living kidney donors are in high demand and represent a large portion of grafts supplied for kidney transplant. The primary objective of our study is to initiate an enhanced recovery after surgery pathway designed to facilitate early recovery and to study the impact of an ERAS protocol on the living donor nephrectomy population.
The study is a prospective, randomized, controlled clinical trial evaluating the effect of ERAS to decrease postoperative opioid consumption, improve pain scores, decrease length of hospital stay, lower morbidity, and increase patient satisfaction. Patients will complete standard preoperative workup as per protocol for donor nephrectomy, and they will also be evaluated at the preadmission testing clinic. Consent will be obtained by a member of the research team at a preoperative office visit. At this time, patients will be randomized to enhanced recovery after surgery (ERAS) pathway or standard of care, and they will be informed on what to expect during their hospital course.
ERAS pathway:
Preoperatively, according to the ERAS pathway devised, patients will be counseled on optimization of physical status. They will be encouraged to sustain from smoking and alcohol, exercise daily, and encourage healthy diet. If the physician determines the need for nutritional counsel, they will have a workup by a nutritionist. They will also be labeled as ERAS pathway in the case request submitted by the surgeon. For the day of surgery, patients will receive carbohydrate drinks and dietary instructions. All patients will be instructed to have a clear liquid diet 24 hours prior to surgery with no food after midnight. Patients will receive 2 carbohydrate pre-surgery drinks (20 oz total) - 10oz for the night before surgery, and 10oz to drink within 1 hour of scheduled arrival time. On arrival the day of surgery, patients will receive the following medications, unless contraindicated or allergy: acetaminophen 1g PO, pregabalin 150 mg PO, and celecoxib 400 mg PO.
Patients will be evaluated in the preoperative holding area by a member of the anesthesiology staff. Peripheral IV will be placed. Patients will be screened for risk of post-operative nausea and vomiting (PONV) (female, nonsmoker, prior PONV, planned postoperative opioid each 1 point), if deemed high risk a scopolamine patch will be applied in holding. Patients will at that point be counseled on use of regional anesthesia for postoperative pain and additional consent for transabdominal plane and rectus sheath blocks will be obtained. Premedication with midazolam will be administered. Subcutaneous heparin 5000 units will be given prior to surgery, as per standard of care.
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
- 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
- 是
入选标准
- •All patients undergoing this procedure who consent
排除标准
- •patient refusal, female patients who are pregnant or nursing, patients with allergy to local anesthetic, American Society of Anesthesiology classification greater than 3
结局指标
主要结局
post operative opioid consumption
时间窗: from time after discharge from PACU to discharge from the hospital (up to 7 days)
amount of opioid pain medication required post operatively
次要结局
- duration of hospitalization(from arrival on day of surgery to discharge from hospital (up to 7 days, anticipated 3 days))
- time to return of bowel function(arrival to PACU until discharge from hospital (up to 7 days))
- time to first oral intake(from arrival to PACU until post-operative day 2 (48 hours))
- patient satisfaction(from discharge from PACU post operative day one to discharge home on last day of hospitalization (up to 7 days))