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Trial record 22 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

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

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ClinicalTrials.gov Identifier: NCT02292082
Recruitment Status : Completed
First Posted : November 17, 2014
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions 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
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block
Hide 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
Arm/Group Title Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block Total
Hide 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 Number of Baseline Participants 56 55 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 111 participants
64.7  (9.6) 66.9  (6.6) 65.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Female
33
  58.9%
34
  61.8%
67
  60.4%
Male
23
  41.1%
21
  38.2%
44
  39.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   0.9%
Asian
1
   1.8%
0
   0.0%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  12.5%
3
   5.5%
10
   9.0%
White
44
  78.6%
46
  83.6%
90
  81.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   7.1%
5
   9.1%
9
   8.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants 55 participants 111 participants
56 55 111
1.Primary Outcome
Title Time to Meet Physical Therapy Discharge Criteria
Hide Description Time to reach physical therapy (PT) goals
Time Frame First 3 days post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block
Hide 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

Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Minutes
2109.3  (1232.8) 1883.1  (846.2)
2.Secondary Outcome
Title Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.3  (2.6) 3.9  (2.6)
3.Secondary Outcome
Title NRS Pain Score With Movement POD2
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 34 32
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.7  (1.6) 5.2  (2.1)
4.Secondary Outcome
Title Opioid Consumption Postoperative Day (POD) 1
Hide Description Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)
Time Frame 0-24 hours postoperatively
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: mg OME
58.4  (37.8) 47.5  (40.3)
5.Secondary Outcome
Title Opioid Consumption POD2
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 41 37
Mean (Standard Deviation)
Unit of Measure: mg OME
67.9  (49.1) 60.1  (48.8)
6.Secondary Outcome
Title Hospital Length of Stay
Hide Description Measured in minutes.
Time Frame Average of 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block
Hide 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

Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Minutes
3491  (1151.7) 3394.4  (945.2)
7.Secondary Outcome
Title Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 53 52
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 53 52
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.9  (2.3) 6.6  (2.3)
11.Secondary Outcome
Title Knee Society Score (KSS) at 6 Weeks Postoperatively
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
85.2  (20) 75.2  (17.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block
Hide 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 (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/55 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Peri-Articular Injections Only Peri-Articular Injections and Adductor Canal Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/55 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: George Birch
Organization: Hospital for Special Surgery
Phone: 2127747377
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02292082     History of Changes
Other Study ID Numbers: 2014-018
First Submitted: November 10, 2014
First Posted: November 17, 2014
Results First Submitted: August 1, 2018
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019