NCT02292082已完成4 期
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Time to Meet Physical Therapy Discharge Criteria
研究概览
简要总结
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.
详细描述
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.
Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.
Time to reach discharge criteria based on physical therapy assessments will also be measured.
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, Care Provider)
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
- •Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
- •Age 18 to 80 years
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (secondary outcomes include questionnaires validated in English only)
排除标准
- •Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability
研究组 & 干预措施
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Bupivacaine (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Morphine (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Methylprednisolone (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Cefazolin (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Normal saline (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Midazolam (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Propofol (Drug)
Peri-Articular Injections only
Active Comparator
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Surgeon will perform the periarticular injections:
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
- Intravenous sedation with midazolam and propofol.
干预措施: Dexamethasone (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Bupivacaine (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Morphine (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Methylprednisolone (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Cefazolin (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Normal saline (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Midazolam (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Propofol (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: Dexamethasone (Drug)
Peri-Articular Injections and Adductor Canal Block
Experimental
Intra-Operatively
- Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
- Adductor canal block technique:
- Supine position, after IV sedation
- Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
- Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
- 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
- Local anesthetic will be delivered periarterial between 12 and 6 o'clock
- Intravenous sedation with midazolam and propofol.
- First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
- Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
干预措施: 8 MHz. Chiba needle, 22 G / 4 inches (Device)
结局指标
主要结局
Time to Meet Physical Therapy Discharge Criteria
时间窗: First 3 days post-operatively
Time to reach physical therapy (PT) goals
次要结局
- Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively(Participants will be followed for the duration of 2 days post operatively in the hospital)
- Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively(24-48 hours postoperative)
- Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively(0-24 hours postoperatively)
- Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively(24-48 hours postoperative)
- Knee Society Score (KSS) at 6 Weeks Postoperatively(Post operatively at approximately 6 weeks after surgery)
- Hospital Length of Stay(Average of 3 days)
- Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1(24 hours after operating room discharge)
- NRS Pain Score With Movement POD2(48 hours after surgery)
- Opioid Consumption Postoperative Day (POD) 1(0-24 hours postoperatively)
- Opioid Consumption POD2(24-48 hours postoperative)
研究者
研究点 (1)
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