Improving Pain Management and Decreasing Length of Stay After THA and TKA: A Randomized, Patient-Blinded Comparison of Standard of Care Pain Management With and Without Sufentanil
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
This two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay when comparing standard of care pain management with and without sufentanil.
详细描述
This two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay (LOS) when comparing standard of care pain management with and without sufentanil. The objective is to compare LOS between patients who have had primary THA or TKA and have received standard of care peri-operative pain management and one dose of sufentanil 30 mcg sublingual pre-operatively in the operating room and one dose post-operatively in the post anesthesia care unit (PACU) versus those who have received only standard of care peri-operative pain management in a orthopedic specialty hospital.
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
- Single (Participant)
盲法说明
participant will not be informed whether participant is in the standard of care arm or treatment arm.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 50 to 80 years, inclusive
- •Planned primary THA or TKA
- •Expressed willingness to be discharged the same day of surgery if condition allows
- •American Society of Anesthesiologists (ASA) physical classes I - III
- •ASA I: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
- •ASA II: A patient with a mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker or is a cigarette smoker).
- •ASA III: A patient with a severe systemic disease that is not life-threatening. Example: Patient with some functional limitation as a result of disease (e.g., poorly treated hypertension or diabetes, morbid obesity, chronic renal failure, a bronchospastic disease with intermittent exacerbation, stable angina, implanted pacemaker).
- •Patients who are English competent.
排除标准
- •Opioid tolerant (> 50 mg oral morphine milligram equivalents (MMEs) daily)
- •Current IV drug abuse
- •History of alcoholism
- •History of severe renal impairment
- •History of severe hepatic impairment
- •Dependent on supplemental oxygen at home
- •Incarcerated
- •Patient unable to provide informed consent
- •Patients undergoing bilateral TKA, THA
- •Patient undergoing unicompartmental knee arthroplasty (UKA)
- •Patients undergoing other concurrent surgery
- •Patients with a history of allergy to any drugs in the study.
研究组 & 干预措施
Treatment
One dose of sufentanil 30 mcg sublingual will be given pre-operatively when entering the operating room and one dose post-operatively in the PACU in addition to standard of care pain management.
干预措施: sufentanil (Drug)
结局指标
主要结局
Length of stay
时间窗: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission
length of hospital stay
Discharge location
时间窗: At date of discharge from hospital, assessed up to 3 days after hospital admission
Discharged from the PACU instead of the Medical-Surgical Unit
次要结局
- physical therapy(From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery)
- side effect(s)(From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission)
- patient satisfaction(At date and time of discharge from the hospital, within 3 days following hospital admission)
- hospital costs(From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission)
- morphine milligram equivalent (MME) doses(From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission)