A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects.
In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- Rothman Orthopaedic Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients who have general anesthesia
- Patients who have documented allergic reactions to ropivacaine in the local infiltration agents
- Patients who have a contra-indication to the use of non-steroidal anti-inflammatory medications or are using therapeutic anticoagulation precluding them from using non-steroidal anti-inflammatory medications
- Patients unable to complete a 100-ft walk baseline
- Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery
- Patients undergoing TKA for posttraumatic arthritis
- Patients undergoing TKA for steroid-induced or spontaneous avascular necrosis
- Workers compensation patients
- Patients refusing or not candidates for peripheral nerve blocks
- Patients undergoing unicompartmental knee arthroplasty
- Patients undergoing patellofemoral arthroplasty
- Patients undergoing bilateral simultaneous or sequential primary total knee arthroplasty within the same hospital stay
- Patients who have previously reported allergy to tetrahydrocannabinol or other cannabinoid compounds or develop allergic reactions to the formulation following use
- Patients who are pregnant or choosing to be pregnant during the 6-week study period or are breast feeding during the study period
- Patients who are on chronic narcotics pre-operatively
- Patients who have end-stage cirrhosis, end-stage renal failures, or psychiatric conditions preventing adequate assessment of study outcome metrics
- Patients with adequate cognitive function to participate and complete questionnaires for the study.
- Patients unable or unwilling to follow-up and complete questionnaires for the study
- Patients with active cancer and undergoing treatment precluding the assessment of outcome metrics
- Patients with a history or diagnosis of chronic pain syndrome or Complex regional pain syndrome (CRPS)
- Patients who are determined to be in severe pain from other concomitant conditions
Exclusion Criteria:
- patients <18 and >80
- any patient who does not meet the inclusion criteria listed for this study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Group 1: (CBD + MO cohort)
Roll on stick containing CBD and mineral oils (CBD + MO cohort)
|
CBD oil Roll-On Stick
Mineral Oil- Roll on Stick
|
|
有源比较器:Group 2: (MO cohort)
Roll on stick containing mineral oils only (MO cohort)
|
Mineral Oil- Roll on Stick
|
|
有源比较器:Group 3: (CBD Cohort)
Roll on stick containing CBD only (CBD cohort)
|
CBD oil Roll-On Stick
|
|
安慰剂比较:Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)
Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort)
|
Roll- On stick with no CBD and no Mineral Oil
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative change in pain and change the need for opiates after total knee arthroplasty.
大体时间:14 days
|
opioid consumption after surgery will be calculated in morphine equivalents
|
14 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.