Achieving Peri-Operative Pain Control Without Opioids
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of Breakthrough Pain
研究概览
简要总结
Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
详细描述
Death from opioid overdose is now considered a national emergency. Prescribing of narcotics by physicians, particularly in the perioperative period, remains a significant contributor to opioid addiction. There is a critical need to identify post-operative pain control alternatives that eliminate narcotic usage. Without such information, clinicians will continue to rely on opioids to manage their patients' pain. Prior work supports the notion that there is little difference between the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) and that of opioid analgesics in controlling pain following surgical procedures. Recent clinical trials have concluded that a combination of centrally and peripherally acting analgesics improves patients' satisfaction and pain control. Clinical investigators have focused upon limiting opioid use rather than on eliminating the administration of narcotics. not surprisingly, there are no established evidenced-based guidelines for postoperative outpatient non-opioid pain control. The majority of U.S. surgeons continue to rely on opioids as the sole outpatient pain regimen, as suggested by a number of current guidelines.
Our observation is that adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
The amount of opioids prescribed at discharge after laparoscopic appendectomies and cholecystectomies is quite variable. An average prescription is for 200-350 Oral Morphine Equivalents (OME) or 26-46 tabs of 5mg oxycodone with the lowest amount reported of 150 OME (20 tabs of 5mg oxy). One of the most conservative guidelines, the Michigan Surgical Quality Collaborative, recommends prescription of 75 OME after laparoscopic cholecystectomy
AIMS AND OBJECTIVES.
- Characterize the need for breakthrough pain medication in a cohort of post-operative subjects treated utilizing a 3-day pain regimen consisting of ibuprofen and acetaminophen for postoperative outpatient pain control without the use of opioids.
- Test the non-inferiority of a regimen consisting of ibuprofen when prescribed on as needed basis in controlling breakthrough pain compared with a regimen using oxycodone.
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)
盲法说明
Quadruple Blinded
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-90
- •English or Spanish speaking
- •Undergoing routine laparoscopic appendectomy or cholecystectomy
- •Able to provide Informed Consent
排除标准
- •Current use of methadone
- •Opioid use within 30 days prior to hospitalization
- •Actively taking anti-inflammatory medications
- •History of Adverse Reactions to Study Medications
- •Pregnancy
- •Currently Breastfeeding
- •Ongoing treatment for Peptic Ulcer Disease
- •Hepatitis, cirrhosis, severe liver dysfunction (elevated MELD score or LFT's > twice the upper limit of normal.)
- •Renal dysfunction with a creatinine more than 25% above age normal values.
- •Taking any medicine that might interact with one of the study medications such as SSRI's or Tricyclics, anti-psychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort
- •The subject will be withdrawn from the study prior to any randomization if the following occurs:
- •Conversion from laparoscopic to open procedure
- •Subject does not undergo any operation;
- •Subject has a complicated hospital course requiring prolonged hospitalization; subject experiences post-operative complications.
研究组 & 干预措施
Arm 1 - Ibuprofen Breakthrough
600 mg Ibuprofen for breakthrough pain.
干预措施: Ibuprofen 600 mg (Drug)
Arm 2 - Oxycodone Breakthrough
5 mg of Oxycodone for breakthrough pain.
干预措施: OxyCODONE 5 Mg Oral Capsule (Drug)
结局指标
主要结局
Incidence of Breakthrough Pain
时间窗: 7 Days
The need for breakthrough pain medication will be characterized by the estimate of the incidence density for starting breakthrough medication. We will examine potential predictors of the need for breakthrough medication using an actuarial approach
次要结局
- Time-weighted average daily pain score over first three days post-discharge.(3 Days)