Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain levels in the first 16 hours after surgery
研究概览
简要总结
The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2).
This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tibial plateau fracture that requires operative fixation
- •Ambulatory patient prior to fracture
排除标准
- •Previous tibial plateau fracture on ipsilateral knee
- •History of Complex Regional Pain Syndrome in ipsilateral extremity
- •History of any demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance/sensation
- •Acute or chronic knee infection in ipsilateral extremity
- •Previous total knee arthroplasty or knee hemiarthroplasty in ipsilateral knee
- •Allergy to morphine (used in the SOC PCA pump)
- •Pregnant or breastfeeding as determined by standard of care pre-operative urine pregnancy test
- •Polytrauma
- •Open fracture
- •IV drug user
- •Rheumatoid arthritis
- •Revision cases
- •Non-ambulatory
- •Anatomical deformities of the knee
- •Hepatic dysfunction or cirrhosis
- •Taking Selective Serotonin Reuptake Inhibitor (SSRI), serotonin-norepinephrine reuptake Inhibitor (SNRI), monoamine oxidase inhibitors (MAOIs), tri- or tetra- cyclic anti-depressant
- •Renal impairment (mention in patient chart and/or creatinine clearance <30)
- •Moderate to severe depression
- •Taking CYP1A2 inhibitors and CYP1A6 inhibitors
研究组 & 干预措施
Group A Placebo
Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.
干预措施: Placebo (Other)
Group A Placebo
Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.
干预措施: Standard of care (SOC) for tibial plateau surgery (Other)
Groups B Intervention
Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.
干预措施: Duloxetine (Drug)
Groups B Intervention
Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.
干预措施: Standard of care (SOC) for tibial plateau surgery (Other)
结局指标
主要结局
Pain levels in the first 16 hours after surgery
时间窗: every 4 hours up to 16 hours
A visual analog pain scale (VAS) will be used to assess postoperative pain levels. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.
Pain level 36 hours after surgery
时间窗: 36 hours
A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.
Pain level 24 hours after surgery
时间窗: 24 hours
A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.
次要结局
- Ambulation (walking) distance on post-op days 1 or 2(Up to 2 days post op)
- Self reported functional status at 12 weeks(12 weeks)
- Hospital length of stay(12 weeks)
- Time to mobilization (starting to walk)(12 weeks)
- Change in knee range of motion(6 weeks, 12 weeks)
- Total morphine consumption(up to 10 days post op)
- Self reported functional status at 6 weeks(6 weeks)