Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Consumption 24-48 hours post-operatively
研究概览
简要总结
The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are:
- Does perioperative dronabinol use (starting in the immediate preoperative period (enrollment before 1 PM), with BID dosing concluding the evening of POD2) affect postoperative opioid consumption 24-48 hours following total knee arthroplasty?
- Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation?
- Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control?
- Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients?
- Is there a change in number of postoperative oxygen desaturation events in patients following total knee arthroplasty based on perioperative dronabinol use?
Participants will:
- Be randomized to take the dronabinol or placebo medication in 5 dosage
- Answer survey questions in regard to pain, postop nausea/vomiting, cognitive/adverse event, and outcome quality and support of decision making.
- Be connected to a Masimo to record oxygen saturation and an Actigraph to record sleep quality.
Researchers will compare two groups: 1) intervention group and 2) control group to see if dronabinol affect postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.
详细描述
The objective of this study is to examine the possible therapeutic advantages of administering perioperative dronabinol to individuals who are undergoing unilateral total knee arthroplasty (TKA). With the utilization of contemporary regional anesthetic procedures and peripheral nerve blocks, pain management is typically effective in the immediate aftermath of total knee arthroplasty (TKA) within the first day after surgery. Rebound pain is shown to occur on the second day following postoperative discharge (POD2), once the analgesic blocks administered during the procedure have ceased to be effective. Previous studies have suggested that dronabinol, a synthetic form of THC, may have potential analgesic properties. Our goal is to find out if giving dronabinol before surgery could lower the number of opioids that people need on postoperative day 2 (POD2) in people who are having total knee arthroplasty (TKA). This research could provide valuable insights into alternative pain management strategies for TKA patients, potentially minimizing opioid-related side effects and improving overall patient outcomes.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Throughout cannabinoid research, there has been concern about potential unblinding due to the side effect profile of this class of medication. Prior meta-analyses have advocated for the use of active placebo, with concern that unblinding may misrepresent the effects of clinical trials. However, due to evidence of histamine receptor involvement in pain transmission, as well as overlap in antihistamine antiemetic use and common cannabinoid side effect profiles, we have chosen to use non-active placebo. Our hope is to elicit maximum benefit of cannabinoid dosing perioperatively without confounding variables. With use of non-active placebo, we will perform a comprehensive blinding analysis following the study period to ensure adequate blinding.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18-70 years old with osteoarthrosis scheduled for primary unilateral knee arthroplasty with a participating surgeon
- •Planned use of regional anesthetic technique during surgery involving infiltration between the popliteal artery and the capsule of the posterior knee (IPACK), adductor canal block (ACB) and periarticular injection (PAI)
- •Ability to follow study protocol
排除标准
- •Patients less than 18 years of age or older than 70 years of age
- •Contraindication to regional or neuraxial anesthetic
- •Intended use of general anesthesia
- •Revision surgery
- •Chronic opioid use (for >3 months prior to surgery)
- •Cannabis/cannabinoid use within the last 3 months
- •ASA class of IV or greater
- •Active or history of major mental history (as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 [DSM-5]; i.e. major depressive disorder, anxiety, bipolar disorder, schizophrenia)
- •History of seizures
- •Use of antidepressants
- •Use of anticonvulsants
- •Use of Coumadin
- •Use of Disulfuram
- •Use of Metronidazole
- •Non-English speakers
研究组 & 干预措施
Dronabinol
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
干预措施: Dronabinol 5mg Cap (Drug)
Placebo
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
干预措施: Placebo oral tablet (Other)
结局指标
主要结局
Cumulative Opioid Consumption 24-48 hours post-operatively
时间窗: 24-48 hours post-operatively
The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured throughout the patient hospitalization and conclude at 48 hours after anesthesia stop time.
次要结局
- Length of hospital stay (hours)(Post operative day 0 (beginning in the PACU)-Discharge, assessed up to 7 days)
- Time to reach discharge from physical therapy(Post operative day 0 (beginning in the PACU)-Discharge, assessed up to 7 days)
- Average pain score with ambulation reported on a numeric rating scale (NRS)(Post operative day 1, 3, 7, 90 and 180)
- Opioid-Related Symptom Distress (ORSDS) Scale(24 hours post operative discharge, 48 hours post operative discharge)
- Average pain score at rest reported on a numeric rating scale (NRS)(Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180)
- Percentage of time and total time of desaturation events(Post operative day 0 (beginning in the PACU)-48 hours post operative discharge)
- PainOUT score(24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge)
- DN4 score(24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge)
- Non-opioid analgesic consumption(24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge)
- Sleep disturbance(Post operative day 0 (beginning in the PACU)- 48 hours post operative discharge)