Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 主要终点
- Length of hospital stay
研究概览
简要总结
Kidney donors represent healthy patients and their anticipated postoperative course should be uncomplicated and brief. This study looks to optimize the perioperative pain regimen of laparoscopic donor nephrectomy patients by minimizing or eliminating narcotics from the immediate post-operative period. Current postoperative standard of care after donor nephrectomy require narcotic analgesics. While narcotics are potent pain medications, they are often associated with complications including nausea, vomiting and dysfunction of the gastrointestinal tract causing prolonged complications.
The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics. This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug (NSAID), intravenous acetaminophen, and intravenous ketamine. All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use.
Prior to surgery, participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia (PCA) by itself plus placebo or along with the new protocol. The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period.
Upon discharge from the hospital, patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction, renal function and quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 individuals undergoing laparoscopic donor nephrectomies at Stony Brook Hospital
排除标准
- •Patients excluded as a potential kidney donor or surgical candidate (renal failure, cancer, uncontrolled hypertension or diabetes, cognitively impaired adults, children, history of stroke, complicated coronary history or pregnant)
- •Patients with a history of chronic pain or chronic pain medication use
- •Patients who are undergoing open nephrectomies
- •Allergy to NSAID or acetaminophen
- •Hepatic disease or elevated transaminases
- •Peptic Ulcer Disease
- •Probenecid use
- •History of traumatic brain injury
- •Contraindications of Ketamine Use (recent head trauma, open eye injury or glaucoma)
研究组 & 干预措施
Ketamine
Patients in this group will receive ketamine, morphine PCA and caldolor for pain control
干预措施: Ketamine (Drug)
placebo
Patients in this group receive placebo, morphine PCA, and caldolor for pain control
干预措施: Placebo (Other)
结局指标
主要结局
Length of hospital stay
时间窗: number of days immediately after the surgery
length of stay after surgery
次要结局
- postoperative renal function (serum creatinine)(up to 2 years after intervention)
- post surgical complication rates(30 day)
- amount of narcotic pain medication use(starting immediately after the surgery, during the inpatient time period)
- postoperative nausea(number of patients reporting postoperative nausea during inpatient time period)
- return of bowel function (passage of flatus)(the number of days after surgery at which return of bowel function is achieved)
- date of postoperative ambulation(reported during inpatient time period)
研究者
FRANK S. DARRAS MD
Principal investigator
Stony Brook University