The Combination of Adductor Canal Block and Periarticular... | NCT02292082

NCT02292082

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Bupivacaine Drug: Morphine Drug: Methylprednisolone Drug: Cefazolin Drug: Normal saline Drug: Midazolam Drug: Propofol Drug: Dexamethasone
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	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

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug		Peri-Articular Injections and Adductor Canal Block Peri-Articular Injections only
Morphine

Outcomes Module

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

Secondary Outcomes

Measure	Description	Time Frame
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1	Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.	24 hours after operating room discharge
NRS Pain Score With Movement POD2

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Enrique A Goytizolo, MD	Hospital for Special Surgery, New York	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Special Surgery		New York	New York	10021	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Mar 24, 2017	Jul 31, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00056 BG00155 BG002111

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.7± 9.6 BG00166.9± 6.6 BG00265.8± 8.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00134 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00056 BG00155 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Meet Physical Therapy Discharge Criteria

Time to reach physical therapy (PT) goals

Posted

Mean

Standard Deviation

Minutes

First 3 days post-operatively

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG00056 OG00155

Title

Denominators

Categories

Title	Measurements
	OG0002109.3± 1232.8 OG0011883.1± 846.2

Secondary

Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1

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

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

Posted

Mean

Standard Deviation

score on a scale

24 hours after operating room discharge

ID	Title	Description
OG000	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
OG001	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

Secondary

NRS Pain Score With Movement POD2

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

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

Posted

Mean

Standard Deviation

score on a scale

48 hours after surgery

ID	Title	Description
OG000	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
OG001	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

Secondary

Opioid Consumption Postoperative Day (POD) 1

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

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

Posted

Mean

Standard Deviation

mg OME

0-24 hours postoperatively

ID	Title	Description
OG000	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
OG001	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

Secondary

Opioid Consumption POD2

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

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

Posted

Mean

Standard Deviation

mg OME

24-48 hours postoperative

ID	Title	Description
OG000	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
OG001	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

Secondary

Hospital Length of Stay

Measured in minutes.

Posted

Mean

Standard Deviation

Minutes

Average of 3 days

ID	Title	Description
OG000	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
OG001	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

Secondary

Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively

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.

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

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively

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

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

Posted

Mean

Standard Deviation

score on a scale

24-48 hours postoperative

ID	Title	Description
OG000	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
OG001	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

Secondary

Patient Outcome Questionnaire (painOUT) Most Pain for 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

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

Posted

Mean

Standard Deviation

score on a scale

0-24 hours postoperatively

ID	Title	Description
OG000	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
OG001	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

Secondary

Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively

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

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

Posted

Mean

Standard Deviation

score on a scale

24-48 hours postoperative

ID	Title	Description
OG000	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
OG001	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

Secondary

Knee Society Score (KSS) at 6 Weeks Postoperatively

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.

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

Posted

Mean

Standard Deviation

score on a scale

Post operatively at approximately 6 weeks after surgery

ID	Title	Description
OG000	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
OG001	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

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	56	0	56	0	56
EG001	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	0	55	0	55	0	55

ID	Term
D010003	Osteoarthritis

ID	Term
D002045	Bupivacaine
D009020	Morphine
D008775	Methylprednisolone
D002437	Cefazolin
D000077330	Saline Solution
D008874	Midazolam
D015742	Propofol
D003907	Dexamethasone

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D001569	Benzodiazepines
D001552	Benzazepines
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013259	Steroids, Fluorinated

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases