The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine
- Conditions
- Osteoarthritis
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Time to Meet Physical Therapy Discharge Criteria
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Peri-Articular Injections only
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.
Intervention: Bupivacaine
Peri-Articular Injections only
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.
Intervention: Morphine
Peri-Articular Injections only
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.
Intervention: Methylprednisolone
Peri-Articular Injections only
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.
Intervention: Cefazolin
Peri-Articular Injections only
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.
Intervention: Normal saline
Peri-Articular Injections only
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.
Intervention: Midazolam
Peri-Articular Injections only
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.
Intervention: Propofol
Peri-Articular Injections only
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.
Intervention: Dexamethasone
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Bupivacaine
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Morphine
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Methylprednisolone
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Cefazolin
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Normal saline
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Midazolam
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Propofol
Peri-Articular Injections and Adductor Canal Block
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
Intervention: Dexamethasone
Peri-Articular Injections and Adductor Canal Block
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
Intervention: 8 MHz. Chiba needle, 22 G / 4 inches
Outcomes
Primary Outcomes
Time to Meet Physical Therapy Discharge Criteria
Time Frame: First 3 days post-operatively
Time to reach physical therapy (PT) goals
Secondary Outcomes
- 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)