Trial Outcomes & Findings for The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI) (NCT NCT02292082)

Results Overview

Time to reach physical therapy (PT) goals

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

111 participants

Primary outcome timeframe

First 3 days post-operatively

Results posted on

2019-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Overall Study STARTED	56	55
Overall Study COMPLETED	56	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peri-Articular Injections Only n=56 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=55 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches	Total n=111 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 9.6 • n=99 Participants	66.9 years STANDARD_DEVIATION 6.6 • n=107 Participants	65.8 years STANDARD_DEVIATION 8.3 • n=206 Participants
Sex: Female, Male Female	33 Participants n=99 Participants	34 Participants n=107 Participants	67 Participants n=206 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	21 Participants n=107 Participants	44 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=99 Participants	51 Participants n=107 Participants	105 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) White	44 Participants n=99 Participants	46 Participants n=107 Participants	90 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Region of Enrollment United States	56 participants n=99 Participants	55 participants n=107 Participants	111 participants n=206 Participants

PRIMARY outcome

Timeframe: First 3 days post-operatively

Time to reach physical therapy (PT) goals

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=56 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=55 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Time to Meet Physical Therapy Discharge Criteria	2109.3 Minutes Standard Deviation 1232.8	1883.1 Minutes Standard Deviation 846.2

SECONDARY outcome

Timeframe: 24 hours after operating room discharge

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, logistical reasons)

Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=53 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=53 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1	4.3 score on a scale Standard Deviation 2.6	3.9 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 48 hours after surgery

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=34 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=32 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
NRS Pain Score With Movement POD2	4.7 score on a scale Standard Deviation 1.6	5.2 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 0-24 hours postoperatively

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=56 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=54 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Opioid Consumption Postoperative Day (POD) 1	58.4 mg OME Standard Deviation 37.8	47.5 mg OME Standard Deviation 40.3

SECONDARY outcome

Timeframe: 24-48 hours postoperative

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=41 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=37 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Opioid Consumption POD2	67.9 mg OME Standard Deviation 49.1	60.1 mg OME Standard Deviation 48.8

SECONDARY outcome

Timeframe: Average of 3 days

Measured in minutes.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=56 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=55 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Hospital Length of Stay	3491 Minutes Standard Deviation 1151.7	3394.4 Minutes Standard Deviation 945.2

SECONDARY outcome

Timeframe: Participants will be followed for the duration of 2 days post operatively in the hospital

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=55 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=55 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively	1.5 score on a scale Standard Deviation 1.8	0.8 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 24-48 hours postoperative

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=34 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=33 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively	1.7 score on a scale Standard Deviation 1.5	1.8 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 0-24 hours postoperatively

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=53 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=52 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively	6.7 score on a scale Standard Deviation 2.5	5.3 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 24-48 hours postoperative

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=53 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=52 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively	6.9 score on a scale Standard Deviation 2.3	6.6 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Post operatively at approximately 6 weeks after surgery

Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)

KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score.

Outcome measures

Outcome measures
Measure	Peri-Articular Injections Only n=17 Participants 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. Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone	Peri-Articular Injections and Adductor Canal Block n=17 Participants 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 Bupivacaine Morphine Methylprednisolone Cefazolin Normal saline Midazolam Propofol Dexamethasone 8 MHz. Chiba needle, 22 G / 4 inches
Knee Society Score (KSS) at 6 Weeks Postoperatively	85.2 score on a scale Standard Deviation 20	75.2 score on a scale Standard Deviation 17.7

Adverse Events

Peri-Articular Injections Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peri-Articular Injections and Adductor Canal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George Birch

Hospital for Special Surgery

Phone: 2127747377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place