Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Current Pain Intensity Level
研究概览
简要总结
There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia.
详细描述
Perioperative pain is often managed by opioids. However, post surgical pain management with opioids can often lead to long-term opioid use; additionally, opioids can cause unwanted side effects including respiratory depression that can lead to hypoxia and respiratory arrest, as well as nausea, vomiting, pruritus, ileus, and constipation. As an alternative to opioid perioperative pain management, non-opioid analgesia has been proven to be as effective as opioid management in acute pain. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and acetaminophen are often utilized as alternatives to opioid analgesia, and have an increased efficacy when combined. Both NSAIDS and acetaminophen have been proven to decrease opioid requirements and have minimized opiate-induced adverse events.
In this randomized clinical trial, pain outcomes after ureteroscopy and percutaneous nephrolithotomy will be investigated in patients who are treated with opioids versus a non-opioid regimen of ketorolac and acetaminophen. Percutaneous nephrolithotomy and ureteroscopy are minimally invasive surgical techniques to surgically remove kidney stones. This trial will seek to determine whether non-opioid therapy is noninferior to opioid therapy in the determination of pain intensity as measured by an 11-point numeric rating scale, in which 0 indicates no pain and 10 indicates the worst possible pain, one week after the surgery by telephone call.
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
- 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
- •Men and Women age>18 years old
- •Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
- •Uncomplicated ureteroscopy or percutaneous nephrolithotomy
排除标准
- •Pregnant/Breastfeeding/Possibly Pregnant Patients
- •Pediatric Patients
- •Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen
- •Significant Renal Disease
- •Peptic Ulcer Disease
- •Chronic Pain and recovering opiate use
- •Inability to complete questionnaires
- •Non-mobile patients
- •Patients on methadone
研究组 & 干预措施
Non-Opioid Analgesia
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
干预措施: Ketorolac Oral Tablet [Toradol] (Drug)
Non-Opioid Analgesia
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
干预措施: Acetaminophen (Drug)
Opioid Analgesia
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
干预措施: Oxycodone Acetaminophen (Drug)
结局指标
主要结局
Current Pain Intensity Level
时间窗: 1 week post surgery
The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity.
Perception of an Acceptable Pain Intensity Level
时间窗: 1 week post surgery
The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level.
Satisfaction With Pain Relief
时间窗: 1 week post surgery
The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief
Peak Pain Intensity Level
时间窗: 1 week post surgery
The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery
Average Pain Intensity Level
时间窗: 1 week post surgery
The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity.
次要结局
- Rates of Constipation(1 week post surgery)
- Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery(1 week post surgery)