Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty: A Double-blinded Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Opioid Use
研究概览
简要总结
Post-discharge pain after total knee arthroplasty remains problematic; many patients have excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has become a national goal, due to the 'epidemic' in opioid misuse.
In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.
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)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25 to 75 years
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (Primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
- •Patients planning on being discharged home or to a rehabilitation center that has agreed to participate
排除标准
- •Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
- •Hepatic insufficiency
- •o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2
- •Renal insufficiency (ESRD, HD, estimated creatinine clearance < 50 ml/min)
- •Severe CRI may impair duloxetine clearance
- •CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)]
- •Patients younger than 25 years old and older than 75
- •Patients intending to receive general anesthesia
- •Allergy or intolerance to one of the study medications
- •Patients with an ASA of IV
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Patients with major prior ipsilateral open knee surgery.
- •Chronic opioid use (taking opioids for longer than 3 months)
- •However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study.
- •This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.
研究组 & 干预措施
Duloxetine ("Cymbalta")
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
干预措施: Cymbalta (Drug)
Placebo
Placebo to compare pain scores and opioid use againts Duloxetine
干预措施: Placebo (Other)
结局指标
主要结局
Opioid Use
时间窗: Post-operative day 14
Opioid use (measured in cumulative morphine equivalents)
Pain Scores
时间窗: Post-operative day 14
Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome.
次要结局
- Pain Phenotype(Day of surgery)