A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Amount of Pain Experienced
研究概览
简要总结
The primary objective of this trial is to determine whether the combination of three non-opioid analgesics (multimodal analgesia) can significantly reduce or eliminate the need for opioids after ambulatory surgery.
A secondary objective would be to present credible data for insurance providers about the opioid sparing effect of these medications. This data may encourage insurance providers to support payment for short term use of certain analgesics that currently require prior authorization.
详细描述
Prescription opioids are associated with addiction and accidental overdose, yet they continue to be the most commonly prescribed analgesics after ambulatory surgery.
Multimodal analgesia is a promising alternative to opioids. It is based on the theory that a combination of more than one analgesic (with non-opioid mechanisms of action) can provide pain relief equal to or exceeding that of traditional opioids.
Multimodal analgesia is not associated with opioid related side effects such as respiratory depression, nausea, constipation, and itching.
Implementation of multi-modal analgesia in an ambulatory setting is challenging for a number of reasons.
First, patient compliance with multiple medications and complex dosing schedules is poor.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between the ages of 18 and 65 having one of three elective procedures as an outpatient. These procedures are associated with moderate to severe postoperative pain (anterior cruciate ligament reconstruction (knee), ankle ligament reconstruction (foot/ankle), or ligament reconstruction with tendon interposition (hand))
- •Patients should have operative risk category of American Society of Anesthesiologists (ASA) 1 or 2 .
- •Patients weighing between 70-100kg will be included to allow standardization of medication dosing
排除标准
- •Allergy to Study Medications
- •Previous History of Chronic Opioid Use
- •Patient Refusal to Participate
- •Known of Suspected History of Sleep Apnea
- •Known History of Chronic Pain Syndrome
- •Weight less than 70kg or greater than 100kg due to standardization of medication doses.
- •Revision Surgery
- •Inability to take study medications due to medication incompatibility or co-existing disease
- •Patients refusing or unable to receive US guided nerve block for postoperative pain
- •Patients unable to read and comprehend written consent document
研究组 & 干预措施
multi-modal
3 Different Non-opioid pain medication taken every 6 hours
Celecoxib 100mg
Acetaminophen 325mg
Pregabalin 50 mg
Plus, for breakthrough pain
oxycodone 5-10 mg will be taken every 4 hours as needed for pain.
干预措施: Pregabalin (Drug)
multi-modal
3 Different Non-opioid pain medication taken every 6 hours
Celecoxib 100mg
Acetaminophen 325mg
Pregabalin 50 mg
Plus, for breakthrough pain
oxycodone 5-10 mg will be taken every 4 hours as needed for pain.
干预措施: Celecoxib (Drug)
multi-modal
3 Different Non-opioid pain medication taken every 6 hours
Celecoxib 100mg
Acetaminophen 325mg
Pregabalin 50 mg
Plus, for breakthrough pain
oxycodone 5-10 mg will be taken every 4 hours as needed for pain.
干预措施: Acetaminophen (Drug)
multi-modal
3 Different Non-opioid pain medication taken every 6 hours
Celecoxib 100mg
Acetaminophen 325mg
Pregabalin 50 mg
Plus, for breakthrough pain
oxycodone 5-10 mg will be taken every 4 hours as needed for pain.
干预措施: Oxycodone (Drug)
Control
7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain.
干预措施: Percocet (Drug)
结局指标
主要结局
Amount of Pain Experienced
时间窗: Cumulative every day after 6 days post-operative
Pain as measured by a 0-10 Visual Analog Scale (VAS) pain scale, where "0" is the lowest score and "10" is the highest score. For example, 10 would be severe pain and 0 would be none. Cumulative scores were the total scores over 6 days and were expressed with the absolute totals with range. No subscales were used. Cumulative scores represent the absolute sum of each data point for 6 days. The total cumulative range for pain is 0-60.
次要结局
- Amount of Nausea Experienced(Cumulative every day after 6 days post-operative)
- Amount of Itching Experienced(Cumulative every day after 6 days post-operative)
- Amount of Oxycodone Used(Cumulative every day after 6 days post-operative)