NCT04539730撤回4 期
Does the Addition of Liposomal Bupivacaine to the Adductor Canal Block Impact Narcotic Use After Primary Total Knee Arthroplasty: a Prospective, Blind Randomized Control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Opioid Use
研究概览
简要总结
The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and study team members involved in data collection and data processing will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is scheduled for elective unilateral primary TKA
- •The subject is ≥ 18 years
- •The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)
- •The patient consents for an adductor canal block
- •Willing and able to sign an informed consent.
排除标准
- •Patients unwilling or unable to consent to participate in the study.
- •Reported to have mental illness or belonging to a vulnerable population.
- •Subject is < 18 years of age.
- •Patients receiving general anesthesia for the total knee arthroplasty.
- •Subject has impaired decision-making capacity per discretion of the Investigator.
- •Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.
- •Significant pre-existing neuropathy on the operative limb.
- •Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I & II, among others).
- •Subject has sustained a significant trauma to the operative knee.
- •Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
- •Known hypersensitivity and/or allergies to local anesthetics.
- •Previous surgery on the affected knee excluding arthroscopic or open meniscectomy.
- •Patients with impaired renal function such that they cannot receive IV Toradol.
研究组 & 干预措施
Liposomal Bupivacaine Intervention Group
Experimental
Participants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Opioid Use
时间窗: Up to 2 weeks
Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents
次要结局
- Post-Operative Pain Score(Up to 5 days)
- Patient Satisfaction as per the Knee Society Score(Up to Week 6)
- Number of participants requiring narcotic prescriptions(2 weeks)
- Distance Ambulated with physical therapist(Up to 5 days)
- Length of hospitalization(Up to 5 days)
- Incidence of events of PONV(Up to 5 days)
- Incidence of urinary retention from narcotic use(2 Weeks)
研究者
Jaime Carvajal Alba
Assistant Professor
University of Miami
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