Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Numerical Rating Scale (NRS) Pain Scores During Hospitalization.
研究概览
简要总结
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.
The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.
Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.
详细描述
Data Collection:
Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively.
Variables
Pre-operative Collection:
- Vital signs
- Hb/Hct
- Age
- Sex
- BMI
- WOMAC Score - Screen Failure at 36 or 12
- Visual Analog Scale (VAS)
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women aged 30 to 85 years
- •Voluntary, written informed consent given to participate in this clinical investigation
排除标准
- •Pregnant or lactating women
- •Presence of allergies or contraindication to any medications indicated in the study
- •Contraindication to or failure of spinal anesthesia
- •Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
- •Patients with a diagnosis of inflammatory arthritis
- •Previous major bone surgery in the operative knee
- •Simultaneous, bilateral TKRs
研究组 & 干预措施
ROP/EPI/TOR/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Ropivacaine (Drug)
ROP/EPI/TOR/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Epinephrine (Drug)
ROP/EPI/TOR/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Toradol (Drug)
ROP/EPI/TOR/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Clonidine (Drug)
ROP/EPI/TOR
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
干预措施: Ropivacaine (Drug)
ROP/EPI
Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml)
干预措施: Ropivacaine (Drug)
ROP/EPI/TOR
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
干预措施: Toradol (Drug)
ROP/EPI/TOR
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
干预措施: Epinephrine (Drug)
ROP/EPI/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Ropivacaine (Drug)
ROP/EPI/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Clonidine (Drug)
ROP/EPI/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
干预措施: Epinephrine (Drug)
ROP/EPI
Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml)
干预措施: Epinephrine (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) Pain Scores During Hospitalization.
时间窗: 2 days after surgery
Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.
次要结局
- Narcotic Consumption During Hospitalization(4 days)
- Knee Society Pain Scores at 6 Week Follow-up Appointment(6 weeks after surgery)
研究者
David F. Dalury, MD
Orthopaedic Surgeon
Towson Orthopaedic Associates