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

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT02292082
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Bupivacaine; Drug: Morphine; Drug: Methylprednisolone; Drug: Cefazolin; Drug: Normal saline; Drug: Midazolam; Drug: Propofol; Drug: Dexamethasone; Device: 8 MHz. Chiba needle, 22 G / 4 inches	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Bupivacaine; Drug: Morphine; Drug: Methylprednisolone; Drug: Cefazolin; Drug: Normal saline; Drug: Midazolam; Drug: Propofol; Drug: Dexamethasone
Experimental: 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	Drug: Bupivacaine; Drug: Morphine; Drug: Methylprednisolone; Drug: Cefazolin; Drug: Normal saline; Drug: Midazolam; Drug: Propofol; Drug: Dexamethasone; Device: 8 MHz. Chiba needle, 22 G / 4 inches

Outcome Measures

Primary Outcome Measures

1. Time to Meet Physical Therapy Discharge Criteria [First 3 days post-operatively]

   Time to reach physical therapy (PT) goals

Secondary Outcome Measures

1. Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1 [24 hours after operating room discharge]

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

2. NRS Pain Score With Movement POD2 [48 hours after surgery]

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

3. Opioid Consumption Postoperative Day (POD) 1 [0-24 hours postoperatively]

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

4. Opioid Consumption POD2 [24-48 hours postoperative]

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

5. Hospital Length of Stay [Average of 3 days]

   Measured in minutes.

6. 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]

   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.

7. Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively [24-48 hours postoperative]

   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

8. Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively [0-24 hours postoperatively]

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

9. Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively [24-48 hours postoperative]

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

10. Knee Society Score (KSS) at 6 Weeks Postoperatively [Post operatively at approximately 6 weeks after surgery]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Enrique A Goytizolo, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Informed Consent Form - Mar 24, 2017
• Study Protocol and Statistical Analysis Plan - Aug 22, 2016

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT02292082
• Other Study ID Numbers: 2014-018
• First Posted: Nov 17, 2014
• Last Update Posted: Jan 11, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Hospital for Special Surgery, New York: Nerve Block; Rehabilitation; Knee Replacement, Total
• Additional relevant MeSH terms: Osteoarthritis; Cefazolin; Dexamethasone; Methylprednisolone; Midazolam; Morphine; Bupivacaine; Propofol

Study Results

Participant Flow

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	56	55
COMPLETED	56	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	56	55	111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (9.6)	66.9 (6.6)	65.8 (8.3)
Sex: Female, Male (Count of Participants)
Female	33 58.9%	34 61.8%	67 60.4%
Male	23 41.1%	21 38.2%	44 39.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.8%	1 1.8%	2 1.8%
Not Hispanic or Latino	54 96.4%	51 92.7%	105 94.6%
Unknown or Not Reported	1 1.8%	3 5.5%	4 3.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.8%	1 0.9%
Asian	1 1.8%	0 0%	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 12.5%	3 5.5%	10 9%
White	44 78.6%	46 83.6%	90 81.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 7.1%	5 9.1%	9 8.1%
Region of Enrollment (participants) [Number]
United States	56 100%	55 100%	111 100%

Outcome Measures

1. Primary Outcome

Title	Time to Meet Physical Therapy Discharge Criteria
Description	Time to reach physical therapy (PT) goals
Time Frame	First 3 days post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	56	55
Mean (Standard Deviation) [Minutes]	2109.3 (1232.8)	1883.1 (846.2)

2. Secondary Outcome

Title	Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
Description	Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.
Time Frame	24 hours after operating room discharge

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	53	53
Mean (Standard Deviation) [score on a scale]	4.3 (2.6)	3.9 (2.6)

3. Secondary Outcome

Title	NRS Pain Score With Movement POD2
Description	NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.
Time Frame	48 hours after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	34	32
Mean (Standard Deviation) [score on a scale]	4.7 (1.6)	5.2 (2.1)

4. Secondary Outcome

Title	Opioid Consumption Postoperative Day (POD) 1
Description	Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)
Time Frame	0-24 hours postoperatively

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	56	54
Mean (Standard Deviation) [mg OME]	58.4 (37.8)	47.5 (40.3)

5. Secondary Outcome

Title	Opioid Consumption POD2
Description	Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.
Time Frame	24-48 hours postoperative

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	41	37
Mean (Standard Deviation) [mg OME]	67.9 (49.1)	60.1 (48.8)

6. Secondary Outcome

Title	Hospital Length of Stay
Description	Measured in minutes.
Time Frame	Average of 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	56	55
Mean (Standard Deviation) [Minutes]	3491 (1151.7)	3394.4 (945.2)

7. Secondary Outcome

Title	Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
Description	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.
Time Frame	Participants will be followed for the duration of 2 days post operatively in the hospital

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	55	55
Mean (Standard Deviation) [score on a scale]	1.5 (1.8)	0.8 (1.6)

8. Secondary Outcome

Title	Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
Description	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
Time Frame	24-48 hours postoperative

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	34	33
Mean (Standard Deviation) [score on a scale]	1.7 (1.5)	1.8 (1.5)

9. Secondary Outcome

Title	Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
Description	Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable
Time Frame	0-24 hours postoperatively

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	53	52
Mean (Standard Deviation) [score on a scale]	6.7 (2.5)	5.3 (2.9)

10. Secondary Outcome

Title	Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
Description	Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.
Time Frame	24-48 hours postoperative

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	53	52
Mean (Standard Deviation) [score on a scale]	6.9 (2.3)	6.6 (2.3)

11. Secondary Outcome

Title	Knee Society Score (KSS) at 6 Weeks Postoperatively
Description	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.
Time Frame	Post operatively at approximately 6 weeks after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Peri-Articular Injections Only	Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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	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
Measure Participants	17	17
Mean (Standard Deviation) [score on a scale]	85.2 (20)	75.2 (17.7)

Adverse Events

Arm/Group Title	Peri-Articular Injections Only		Peri-Articular Injections and Adductor Canal Block
Arm/Group Description	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		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
All Cause Mortality
	Peri-Articular Injections Only		Peri-Articular Injections and Adductor Canal Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/55 (0%)
Serious Adverse Events
	Peri-Articular Injections Only		Peri-Articular Injections and Adductor Canal Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Peri-Articular Injections Only		Peri-Articular Injections and Adductor Canal Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.