Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Use of supplemental opioid POD 1-14
研究概览
简要总结
The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone.
详细描述
The purpose of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (TKA) and to determine whether postoperative administration of oral dosage of suzetrigine is effective at reducing postoperative pain versus a control group of patients receiving oral dosage of oxycodone only following primary total knee arthroplasty.
The primary objective will be to compare the amount of postoperative narcotics utilized and postoperative VAS pain levels. The secondary objective will be to compare variables of patient functionality and other patient-reported outcome measures.
The main questions it aims to answer are:
- What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty?
- Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare suzetrigine to a standard postoperative pain control regimen (Oxycodone) to see if suzetrigine is equivalent or more effective at reducing opioid consumption and postoperative pain following primary total knee arthroplasty.
Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age is 21-89 at time of surgery
- •Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- •Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- •Patient is able to read and speak English.
排除标准
- •Patient is under the age of 21
- •Patient's primary diagnosis is not osteoarthritis
- •Patient is unable to read and speak English
- •Contraindication or Hypersensitivity to suzetrigine
- •Pregnant or nursing females
- •Patient has taken opioids within the 90 days prior to enrollment
研究组 & 干预措施
Group A: suzetrigine group
Participant will receive a two-week supply of oral suzetrigine upon discharge. Participant will also receive a 10-pill supply of Oxycodone as a rescue medication.
干预措施: oral suzetrigine (Drug)
Group B: Oxycodone group
Participant will receive a two-week supply of oral Oxycodone upon discharge
干预措施: oral Oxycodone (Drug)
结局指标
主要结局
Use of supplemental opioid POD 1-14
时间窗: 2 weeks
Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)
VAS pain score over two weeks
时间窗: 2 weeks
VAS (Visual Analogue Scale) pain score measuring highest level of knee pain experienced each day for the first 14 days following TKA. Scale 0-10
Opioid Usage at 6 weeks postop
时间窗: 6 weeks
Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage
Daily Opioid Use POD 1-14
时间窗: 2 weeks
Daily opioid use as measured in MME recorded daily for the first two weeks following TKA
total opioid usage over two weeks
时间窗: 2 weeks
total daily opioid usage (as measured in MME) for the first 14 days following TKA
Daily Opioid Use POD 1-14
时间窗: 2 weeks
Daily opioid use as measured in MME recorded daily for the first two weeks following TKA
total opioid usage over two weeks
时间窗: 2 weeks
total daily opioid usage (as measured in MME) for the first 14 days following TKA
Use of supplemental opioid POD 1-14
时间窗: 2 weeks
Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)
VAS pain score over two weeks
时间窗: 2 weeks
VAS (Visual Analogue Scale) pain score measuring highest level of knee pain experienced each day for the first 14 days following TKA. Scale 0-10
Opioid Usage at 6 weeks postop
时间窗: 6 weeks
Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage
次要结局
- KOOS, JR.(preoperatively and 6 weeks (± 2 weeks) postoperatively)
- VAS Pain Score at 6 weeks(6 weeks)
- ROM(preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively)
研究者
Arthur Malkani
Clinical Professor, Chief, Adult Reconstruction
University of Louisville