Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Universal Pain Assessment Tool (UPAT)
研究概览
简要总结
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
详细描述
Data Collection:
Data will be collected from the patient's medical record after discharge
Variables include:
- Age
- Sex
- BMI
- UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
- Patient's assessment of acceptability of pain
- UPAT score as assessed by physical therapy pre and post therapy sessions
- Duramorph dose
- Time patient arrived on the Orthopedic Unit
- Length of ambulation during physical therapy sessions
- Amount of supplementary opioids (measured in morphine equivalents)
- Use of anti-emetics
- Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
- Length of hospital stay
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Written informed consent
排除标准
- •Pregnant women
- •Creatinine clearance less than 60 ml/min
- •BMI greater than 40
- •Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
- •Receive a unicondylar knee replacement
研究组 & 干预措施
ROP/KET/CLON/EPI/SAL
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
干预措施: Ropivacaine (Drug)
ROP/KET/CLON/EPI/SAL
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
干预措施: Ketorolac (Drug)
ROP/KET/CLON/EPI/SAL
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
干预措施: Clonidine (Drug)
ROP/KET/CLON/EPI/SAL
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
干预措施: Epinephrine (Drug)
ROP/KET/CLON/EPI/SAL
Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
干预措施: 0.9% sodium chloride (Drug)
Placebo
0.9% Sodium Chloride- 100ml
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Universal Pain Assessment Tool (UPAT)
时间窗: 3 days after surgery
Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
Narcotic Use During Hospitalization
时间窗: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
次要结局
- Patient's Subjective Rating of Pain(3 days after surgery)
- Ambulation During Physical Therapy(48 hours after surgery)
- UPAT Score Before and After Physical Therapy(3 days after surgery)