A Prospective, Double-blind, Randomized Pilot Study Evaluating the Effects of Toradol and Lyrica Verses Placebo for Pain Control After Donor Nephrectomy (TORPEDO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Cumulative Narcotic Use
研究概览
简要总结
The investigators will assess how the use of toradol and pregabalin affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay.
详细描述
Perioperative pain management is a significant challenge following surgery. Many pathways contribute to perioperative pain, including nociceptive, inflammatory, and neuropathic sources. Although opioids have long been a mainstay for perioperative analgesia, other non-opioid therapies have been increasingly used as part of a multimodal analgesic regimen to provide improved pain control while minimizing opioid-related side effects
TORADOL (ketorolac tromethamine), is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.
Anecdotal evidence has shown that the use of Toradol (Ketorolac) is safe in renal surgery patients. The study team aims to further evaluate this in a pilot study specifically in the population of patient who have donated their kidney in live kidney transplants. The study team will assess how the use of toradol affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay. The study team will assess differences in visual analog pain scores and total narcotic consumption, whereas secondary endpoints of urine output, serum creatinine and hemoglobin levels to assess for efficacy and safety.
Pregabalin is prescribed for neuropathic pain. In many studies, preoperative administration of pregabalin reduced postoperative morphine consumption and early postoperative pain.
There will be two arms of the study including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients anticipating donating a kidney in a live kidney donor transplant.
排除标准
- •Patients not receiving a donor nephrectomy
- •Pregnant, lactating, or nursing mothers
- •Medical allergies or history that would otherwise be contraindicated for of a non-steroidal anti-inflammatory drug.
研究组 & 干预措施
Toradol and Lyrica
Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).
干预措施: Ketorolac (Drug)
Toradol and Lyrica
Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).
干预措施: Pregabalin (Drug)
Placebo and Standard of Care
Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.
干预措施: Placebo oral capsule (Drug)
Placebo and Standard of Care
Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.
干预措施: Saline (Drug)
结局指标
主要结局
Cumulative Narcotic Use
时间窗: 82.25 hours
Cumulative narcotic use was defined by cumulative morphine equivalents over the course of a patient's hospital course. The Washington State Agency Medical Director's Group Opioid dose calculator was used to provide a total morphine dose equivalent (MDE) for each patient while in the hospital.
Length of Hospital Stay
时间窗: 82.25 hours
Primary outcomes include length of hospital stay (LOS).
次要结局
- Serum Creatinine Levels at One Year Post-operatively(1 year)
- Bleeding Risk(24 hours)
- Number of Patients With Urinary Retention(82.25 hours)
- 30 Day Mortality(30 days)
研究者
Jeffrey Campsen
Associate Professor of Transplant Surgery
University of Utah