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Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
1
Multimodal Pain Management:
The Outpatient TJA Setting
Keith R. Berend, MD Joint Implant Surgeons, Inc., White Fence Surgical Suites
New Albany, Ohio
Keith R. Berend, MD Disclosure
♦ Consultant, Speaker’s Bureau:
Biomet, Inc., Pacira
♦ Royalties:
Biomet, Inc.
♦ Research Support:
Biomet, Inc.; Stryker; Piedmont Orthopedic Society; Pacira
♦ Boards:
The Knee Society
Timeline of Arthroplasty Length of Stay
0
1
2
3
4
5
6
7
8
9
10
19
87
19
88
19
89
19
90
19
91
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
Av
era
ge
Le
ng
th o
f S
tay
1991-1992
♦ Same protocol
♦ LOS: 5-7 days
1987-1990
♦ TKA: Robert Jones dressing
♦ THA: Charnley buttons
♦ All patients → Mini ICU
♦ LOS: 7-10 days
1993-1997
♦ Same protocol
♦ Acute setting: 3 days
♦ Adjacent SNF: 7 days
1997-2002
♦ Regional anesthesia (epidurals)
♦ Soft tissue injections
♦ Acute setting: 3-5 days
♦ Outside SNF: 7 days
2003-2004
♦ Single shot spinals
♦ Rapid recovery protocols
♦ Multimodal medications
♦ LOS: 2.5 days
2005-2011
♦ Minimally invasive surgery
♦ LOS: 1.5 days
2012-2013
♦ Liposome bupivacaine suspension injection
♦ Same day surgery
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
2
Why Do Patients Stay in the Hospital?
1. Fear/Anxiety Unknown
Pain
2. Risk Co-morbidities
Medical complications
3. Side-effects of our treatment Narcotics/anesthesia
Blood loss
Surgical trauma
Fear: Preoperative Education
Anxiety
Pain
LOS
Satisfaction Yoon et al., J Arth 2009 Mancuso et al., CORR 2008 Thomas & Sethares, Orthop Nurs 2008 Pietsch & Hofmann, Orthopade 2007 McGregor et al., J Arth 2004 NIH Consensus Statement on TKR, 2003 Sjoling et al., Patient Educ Couns 2003 Crowe & Henderson, Can J Occup Ther 2003 Liebergall et al., Clin Perform Qual Health Care 1999 Daltroy et al., Arthritis Care Res 1998 Claeys et al., Orthop Nurs 1998 Messer, Orthop Nurs 1998 Lin et al., Orthop Nurs 1997 Gammon & Mulholland, Int J Nurs Stud 1996 Livesley & Rider, Int Orthop 1993
Fear: Pre-Arthroplasty Rehabilitation
Reduces anxiety
Prepares patient for peri-operative protocols
Decreases pain and length of stay
Improves outcomes
Rooks et al., Arthritis Rheum 2006 Crowe et al., Can J Occup Ther 2003 Liebergall et al., Clin Perform Qual
Health Care 1999 Daltroy et al., Arthritis Care Res 1998
Topp et al., PM R 2009 Brown et al., J Strength Cond 2009 Jaggers et al., J Strength Cond 2007 Coudeyre et al., Ann Readapt Med Phys 2007
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
3
Risk: Preoperative Medical Clearance
Nierman & Zakrewski, Rheum Dis Clin NA 1999 Clelland et al., South Med J 1996 MacDonald et al., Health Bull (Edinb) 1992
Chan et al., Med J Malaysia 2008 Meding et al., J Arth 2007 King, Am Fam Physician 2000
Side-Effects: Anesthesia, Pain Control, and Blood Loss
Short acting spinal (Hips)
Adductor canal block (Knees)
General anesthesia
Tranexamic Acid 1gm x 2
Pericapsular Injectable Cocktail (Exparel)
IV Tylenol 1000mg x 2
IV Steroid Decadron 10mg/4mg
Celebrex pre and post-op
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
4
TKA UKA P-Value
DVT 11(.5%) 2 (0.3%) 0.744
PE 13 (0.6%) 2 (0.3%) 0.747
Deep infection 18 (0.8%) 1 (0.2%) 0.130
Re-op (90 d) 31(1.4%) 4 (0.6%) 0.064
Death 6 (0.3%) 1 (0.2%) 1.00
TKA trend toward increased VTED, PJI, Re-operation
Re-op (Any) 96 (4.2%) 17 (2.7%) 0.07
Results: Complications
Brown et al J Arthroplasty 2012
A Trend
Developing
Courtesy of Duke University
and Joint Implant Surgeons
Methods
• 5% National sample of Medicare sample of unilateral TKA and UKA
• 1999-2009
• Cox proportional hazard models (p<0.05)
• TKA: 65,685 (1,313,700)
• UKA: 3,105 (62,100)
• 4.7% UKA utilization
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
5
Results: Complications
TKA UKA P-Value
DVT/PE 0.7% 0.3% 0.028
Myocardial 0.4% 0.3% 0.275
Deep infection 2.1% 1.4 0.009
Revision (1yr) 1.2% 2.3% <0.001
Revision (5 yr) 3.7% 8.0% <0.001
TKA Inc. VTED, PJI, Death at 90-days UKA inc. revision at 1 yr and 5 yr
Does not include MUA, wash-out, I&D
procedures (4.2% and 2.7%)
Death (90 d) 0.7% 0.3% 0.014
Courtesy of Duke University
and Joint Implant Surgeons
Death
p=0.01
Infection
p=0.009
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
6
Is there a Difference???
Outpatient
Regional Blocks ♦ Adductor Canal Block
♦ Long acting pericapsular
Gen LM, preop meds
No foley
No labs
Early ambulation
Home environment ♦ Food, home or outpt
rehab, comfort
Adaptable systems
More surgeon-patient interaction
Inpatient
Regional Blocks
♦ Femoral with pump (knee immob)
♦ Sciatic
♦ Spinal (Noctural pulse ox)
Gen LM, preop meds
Foley
Labs x 2
Surgeon rounding
Bed ~ 24 hrs
LOS 1-2 days
Nursing, Pharmacy, PT, room, costs
Inflexible systems
Multiple steakholders
M Berend Outpatient Experience ‘12
♦ 143 UKA
♦ 110 UKA Outpatient
♦ 109 home DOS
1 pt, 18 hr stay for pain control
♦ 2 reoperation for stitch infection
♦ Risk adjusted DVT prophylaxis: No VTE
♦ No Medical Cx so far
♦ High patient satisfaction
MEB: PKA Demographics ‘12
In-patient Out-patient
Total n = 133 n = 110
Average Age 63.2 yrs 63.7 yrs
Age Range 42 - 90 40 - 87
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
7
Outpatient THA: Watson-Jones
113 sequential patients
♦ THA completed by noon
♦ Watson-Jones approach
87 Agreed/eligible for outpatient (77%)
♦ 86 d/c DOS (98.9%)
1 Readmission (1.1%)
Chen and Berger ICL 2013
Single Surgeon Outpatient THA
Sept ‘12-April ’13: primary THA
321 Primary THA
260 Performed at specialty center
40 Scheduled outpatient (15%)
No Transfusions
♦ 35 Discharged home (88%)
• 5 Extended recovery (23 hour) 3 urinary retention
1 oxygen
1 n/v with PT
JIS / Outpatient Surgery Center TJA Experience
♦ Opened June 2013
♦ 4 Surgeons, June - July
♦ 115 arthroplasties (25%)
45 total hips
34 total knees
36 partial knees
♦ Length of stay: avg. 7 hours!
110 went home same day
5 (4%) stayed overnight
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
8
Patient Selection for OutPt Arthroplasty
♦ Medical screening
♦ Acceptable Cardiac History
♦ Function Independently with Walker
♦ Pre-op Physiotherapy Evaluation
Pre-op Education
Written Materials
Family Support at home
♦ Live within 1-2 hours of the center
Or have 23 hour stay capabilities
Outpatient Alternative The reasons TJA “need” to be in hospital
♦ Fear, Risk, Side-effects
Program to eliminate that “need”
♦ Education/pre-hab
♦ Identify appropriate patients
♦ Mitigate side-effects
Safe and efficient for certain patients and procedures
♦ Estimate up to 70% of PKA, THA, TKA
Significant cost savings for patient, hospital, and health care system
Profitability for surgeon
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
1
Multimodal Pain Management:
The Outpatient TJA Setting
Keith R. Berend, MD Joint Implant Surgeons, Inc., White Fence Surgical Suites
New Albany, Ohio
Keith R. Berend, MD Disclosure
♦ Consultant, Speaker’s Bureau:
Biomet, Inc., Pacira
♦ Royalties:
Biomet, Inc.
♦ Research Support:
Biomet, Inc.; Stryker; Piedmont Orthopedic Society; Pacira
♦ Boards:
The Knee Society
Timeline of Arthroplasty Length of Stay
0
1
2
3
4
5
6
7
8
9
10
19
87
19
88
19
89
19
90
19
91
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
Av
era
ge
Le
ng
th o
f S
tay
1991-1992
♦ Same protocol
♦ LOS: 5-7 days
1987-1990
♦ TKA: Robert Jones dressing
♦ THA: Charnley buttons
♦ All patients → Mini ICU
♦ LOS: 7-10 days
1993-1997
♦ Same protocol
♦ Acute setting: 3 days
♦ Adjacent SNF: 7 days
1997-2002
♦ Regional anesthesia (epidurals)
♦ Soft tissue injections
♦ Acute setting: 3-5 days
♦ Outside SNF: 7 days
2003-2004
♦ Single shot spinals
♦ Rapid recovery protocols
♦ Multimodal medications
♦ LOS: 2.5 days
2005-2011
♦ Minimally invasive surgery
♦ LOS: 1.5 days
2012-2013
♦ Liposome bupivacaine suspension injection
♦ Same day surgery
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
2
Why Do Patients Stay in the Hospital?
1. Fear/Anxiety Unknown
Pain
2. Risk Co-morbidities
Medical complications
3. Side-effects of our treatment Narcotics/anesthesia
Blood loss
Surgical trauma
Fear: Preoperative Education
Anxiety
Pain
LOS
Satisfaction Yoon et al., J Arth 2009 Mancuso et al., CORR 2008 Thomas & Sethares, Orthop Nurs 2008 Pietsch & Hofmann, Orthopade 2007 McGregor et al., J Arth 2004 NIH Consensus Statement on TKR, 2003 Sjoling et al., Patient Educ Couns 2003 Crowe & Henderson, Can J Occup Ther 2003 Liebergall et al., Clin Perform Qual Health Care 1999 Daltroy et al., Arthritis Care Res 1998 Claeys et al., Orthop Nurs 1998 Messer, Orthop Nurs 1998 Lin et al., Orthop Nurs 1997 Gammon & Mulholland, Int J Nurs Stud 1996 Livesley & Rider, Int Orthop 1993
Fear: Pre-Arthroplasty Rehabilitation
Reduces anxiety
Prepares patient for peri-operative protocols
Decreases pain and length of stay
Improves outcomes
Rooks et al., Arthritis Rheum 2006 Crowe et al., Can J Occup Ther 2003 Liebergall et al., Clin Perform Qual
Health Care 1999 Daltroy et al., Arthritis Care Res 1998
Topp et al., PM R 2009 Brown et al., J Strength Cond 2009 Jaggers et al., J Strength Cond 2007 Coudeyre et al., Ann Readapt Med Phys 2007
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
3
Risk: Preoperative Medical Clearance
Nierman & Zakrewski, Rheum Dis Clin NA 1999 Clelland et al., South Med J 1996 MacDonald et al., Health Bull (Edinb) 1992
Chan et al., Med J Malaysia 2008 Meding et al., J Arth 2007 King, Am Fam Physician 2000
Side-Effects: Anesthesia, Pain Control, and Blood Loss
Short acting spinal (Hips)
Adductor canal block (Knees)
General anesthesia
Tranexamic Acid 1gm x 2
Pericapsular Injectable Cocktail (Exparel)
IV Tylenol 1000mg x 2
IV Steroid Decadron 10mg/4mg
Celebrex pre and post-op
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
4
TKA UKA P-Value
DVT 11(.5%) 2 (0.3%) 0.744
PE 13 (0.6%) 2 (0.3%) 0.747
Deep infection 18 (0.8%) 1 (0.2%) 0.130
Re-op (90 d) 31(1.4%) 4 (0.6%) 0.064
Death 6 (0.3%) 1 (0.2%) 1.00
TKA trend toward increased VTED, PJI, Re-operation
Re-op (Any) 96 (4.2%) 17 (2.7%) 0.07
Results: Complications
Brown et al J Arthroplasty 2012
A Trend
Developing
Courtesy of Duke University
and Joint Implant Surgeons
Methods
• 5% National sample of Medicare sample of unilateral TKA and UKA
• 1999-2009
• Cox proportional hazard models (p<0.05)
• TKA: 65,685 (1,313,700)
• UKA: 3,105 (62,100)
• 4.7% UKA utilization
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
5
Results: Complications
TKA UKA P-Value
DVT/PE 0.7% 0.3% 0.028
Myocardial 0.4% 0.3% 0.275
Deep infection 2.1% 1.4 0.009
Revision (1yr) 1.2% 2.3% <0.001
Revision (5 yr) 3.7% 8.0% <0.001
TKA Inc. VTED, PJI, Death at 90-days UKA inc. revision at 1 yr and 5 yr
Does not include MUA, wash-out, I&D
procedures (4.2% and 2.7%)
Death (90 d) 0.7% 0.3% 0.014
Courtesy of Duke University
and Joint Implant Surgeons
Death
p=0.01
Infection
p=0.009
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
6
Is there a Difference???
Outpatient
Regional Blocks ♦ Adductor Canal Block
♦ Long acting pericapsular
Gen LM, preop meds
No foley
No labs
Early ambulation
Home environment ♦ Food, home or outpt
rehab, comfort
Adaptable systems
More surgeon-patient interaction
Inpatient
Regional Blocks
♦ Femoral with pump (knee immob)
♦ Sciatic
♦ Spinal (Noctural pulse ox)
Gen LM, preop meds
Foley
Labs x 2
Surgeon rounding
Bed ~ 24 hrs
LOS 1-2 days
Nursing, Pharmacy, PT, room, costs
Inflexible systems
Multiple steakholders
M Berend Outpatient Experience ‘12
♦ 143 UKA
♦ 110 UKA Outpatient
♦ 109 home DOS
1 pt, 18 hr stay for pain control
♦ 2 reoperation for stitch infection
♦ Risk adjusted DVT prophylaxis: No VTE
♦ No Medical Cx so far
♦ High patient satisfaction
MEB: PKA Demographics ‘12
In-patient Out-patient
Total n = 133 n = 110
Average Age 63.2 yrs 63.7 yrs
Age Range 42 - 90 40 - 87
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
7
Outpatient THA: Watson-Jones
113 sequential patients
♦ THA completed by noon
♦ Watson-Jones approach
87 Agreed/eligible for outpatient (77%)
♦ 86 d/c DOS (98.9%)
1 Readmission (1.1%)
Chen and Berger ICL 2013
Single Surgeon Outpatient THA
Sept ‘12-April ’13: primary THA
321 Primary THA
260 Performed at specialty center
40 Scheduled outpatient (15%)
No Transfusions
♦ 35 Discharged home (88%)
• 5 Extended recovery (23 hour) 3 urinary retention
1 oxygen
1 n/v with PT
JIS / Outpatient Surgery Center TJA Experience
♦ Opened June 2013
♦ 4 Surgeons, June - July
♦ 115 arthroplasties (25%)
45 total hips
34 total knees
36 partial knees
♦ Length of stay: avg. 7 hours!
110 went home same day
5 (4%) stayed overnight
Berend ASI Surgical Technique_TIC484_AAOS 2011 11/18/2013
8
Patient Selection for OutPt Arthroplasty
♦ Medical screening
♦ Acceptable Cardiac History
♦ Function Independently with Walker
♦ Pre-op Physiotherapy Evaluation
Pre-op Education
Written Materials
Family Support at home
♦ Live within 1-2 hours of the center
Or have 23 hour stay capabilities
Outpatient Alternative The reasons TJA “need” to be in hospital
♦ Fear, Risk, Side-effects
Program to eliminate that “need”
♦ Education/pre-hab
♦ Identify appropriate patients
♦ Mitigate side-effects
Safe and efficient for certain patients and procedures
♦ Estimate up to 70% of PKA, THA, TKA
Significant cost savings for patient, hospital, and health care system
Profitability for surgeon
11/19/2013
1
Texas Center for Joint Replacement
Improving Patient Outcomes Through Advanced Pain Management Techniques :
Surgical Technique
John W. Barrington, MD
Plano, Texas
Texas Center for Joint Replacement
Disclosures
• Consulting
– Biomet
– Medtronic
– Pacira
– Orthosensor
– Angiotech
Texas Center for Joint Replacement
Pain Management • Stop pain before it
starts – Neuraxial /Regional anaesthesia
• Multimodal analgesia – Transduction, transmission,
perception
• Minimize tissue trauma – UKA: Less exposure required
– Gentle technique: Ioban?
– Plug holes
– Drain
– Elevate!=less swelling=less pain
Multimodal analgesic approach to pain management. ASA = aspirin; LAs = local anesthetics; NSAIDs = nonsteroidal anti-inflammatory drugs; SNRIs = serotonin-norepinephrine reuptake inhibitors; SSRIs = selective serotonin reuptake inhibitors; TCAs = tricyclic antidepressants. Kehlet H, Dahl JB. Anesth Analg. 1993;77:1048-
1056
11/19/2013
2
Texas Center for Joint Replacement
EXPAREL: Indication
• Liposome-bound bupivacaine
• Amide-type local anesthetic
• FDA approved:
• Injection into surgical site to produce post-surgical analgesia
• Safety – 21 clinical trials, >1300 subjects
– 10 double-blind RCT, 823 patients
– Multiple types surgical procedures
– 66 mg to 532 mg of EXPAREL.1
• 266mg/20ml vial
1. Gorfine SR, Onel E, et a l. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing
hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Diseases of the Colon & Rectum. 2011;54(12):1552-1559
Texas Center for Joint Replacement
Surgical Technique: Partial Knee
Texas Center for Joint Replacement
Surgical Technique: ASI Total Hip
11/19/2013
3
Texas Center for Joint Replacement
Technology Introduction-TCJR
• New Product
– Study available data: Phases or FDA approval
• Introduce as Pilot Study
– Review early results, compare to prior
• Large-scale introduction
– Review ongoing data, practice-based registry
• Large Case-Control Study, RCT
Texas Center for Joint Replacement
Large-Scale Introduction & Scientific Study
• Standard of Care at TCJR
• Large Case-Control study—AAOS 2014
– Improved VAS POD 0,1
– LOS
– Falls and $ (FNC)
Liposomal Bupivicaine: the First 1,000 Cases in a New Era John W. Barrington, Roger H. Emerson, Jr. Introduction More than 1.1 million total joint arthroplasties (TJA) are performed annually in the United States, and peri-articular injection (PAI) has been shown in randomized controlled trials to decrease pain and increase function after TJA. The purpose of this prospective case-control study was to compare the first 1,000 cases utilizing a novel extended-release liposomal bupivacaine, to a control group of the previous 1,000 cases without liposomal bupivicaine. Methods Between October 2012 and June 2013, 1,000 consecutive TJA cases were performed by 4 surgeons in one dedicated arthroplasty practice. The previous 1,000 consecutive TJA cases, from January 2012 through October 2012 were used as control, comparing VAS pain scores in PACU, POD 0, 1, and 2 and overall mean VAS score, length of stay, complications, and cost using a two-sample unequal variance Student’s T-test, two-tailed distribution (StatCalc®), with significance level of p<0.05. Power analysis determined that a minimum of 26 patients per group would be required, given a probability level of p=0.05, effect size of 0.8, and statistical power level of 0.80. Results In the first 1,000 TJA cases using liposomal bupivacaine, compared to the previous 1,000 TJA, there were improved overall mean VAS pain scores (p=.003) and on POD 0 (p=0.01) and 1 (p=0.001), but not in the PACU or POD2 (p=NS). Length of stay decreased from 3.2 to 2.9 days (p=0.02). Complications requiring extended length of stay or readmission were not statistically different. Falls were significantly decreased, from 1.2% to 0.2% (p=0.002). Overall cost was decreased on average by $420, predominantly by eliminating femoral nerve catheters. Conclusion This prospective case-control study comparing the first 1,000 cases utilizing a novel extended-release liposomal bupivacaine to a control group demonstrated improved overall mean VAS pain scores and VAS on POD 0 and 1, decreased length of stay, decreased falls, and decreased overall cost.
Texas Center for Joint Replacement
EXPAREL Randomized, Controlled, Blinded Clinical Trial in Primary Unilateral Total Knee Arthroplasty
• Participating Centers:
– Joint Implant Surgeons, Inc., New Albany, Ohio
• Keith Berend, MD (principle Investigator)
• Adolph Lombardi, Jr., MD, FACS
• Jason Hurst, MD
• Mike Morris, MD
– Center for Hip and Knee Surgery, Mooresville, Indiana
• Mike Berend, MD
– Texas Center for Hip and Knee Surgery, Plano, Texas
• John Barrington, MD
• Roger Emerson, MD
9
11/19/2013
4
Texas Center for Joint Replacement
EXPAREL Randomized, Controlled, Blinded Clinical Trial in Primary Unilateral Total Knee Arthroplasty
3 Cohorts Goal to enroll 150 subjects (50 per group/50 per center)
Spinal + EXPAREL
Narcotic Spinal + Ropivacaine
Spinal + Ropivacaine
• 20cc 1.3% EXPAREL
• 25cc .5% Marcaine
• 30mg Toradol
• 1cc of 1:1000 Epinepherine
• Drawn up to 60 cc with sterile NS
Endpoints
1⁰: VAS at 1,6,12,18 hours & POD 1-7; Opioids
2⁰: Cardiff Satisfaction day 14, Ambulation, Opioid ADEs, LOS
• 50cc .2% Naropin
• 30mg Toradol
• 1cc of 1:1000 Epinepherine
• 50cc .2% Naropin
• 30mg Toradol
• 1cc of 1:1000 Epinepherine
Texas Center for Joint Replacement
Thank You for your Attention!
11/18/2013
1
Texas Center for Joint Replacement
Comparison Of A Continuous Femoral Nerve Block To Long-Acting Bupivacaine Wound
Infiltration As Part Of A Multi-Modal Pain Program In Total Knee
Replacement
Roger H. Emerson, Jr., MD
Plano, Texas
Texas Center for Joint Replacement
Disclosures
• Consulting
– Biomet, Medtronic, Pacira
• No financial support received for this presentation
Texas Center for Joint Replacement
Pain score “5th vital sign”
To improve pain management, the Veterans Health Administration launched the “Pain as
the 5th Vital Sign” initiative in 1999, requiring a pain intensity rating (0 to 10) at
all clinical encounters.
11/18/2013
2
Texas Center for Joint Replacement
Satisfaction after TKR?
• Royal Infirmary of Edinburgh
• 1217 consecutive patients
• TKR, 2006 to 2008
• At 1 yr
• 18.6% unsure or dissatisfied
– Scott et al, JBJS Br 92:1253-8. 2010
Texas Center for Joint Replacement
Predictors of dissatisfaction?
Poor improvement in pain element Oxford Knee Score at 1 yr
Independent predictor of dissatisfaction. Significant (p < 0.001)
– Scott et al, JBJS Br 92:1253-8. 2010
Texas Center for Joint Replacement
Satisfaction with Pain Relief
• Cross-sectional study, Province of Ontario
• 1703 primary TKAs,
• Satisfaction with Pain relief, 72-86%
• Bourne et al, CORR 468:57-63, 2010
11/18/2013
3
Texas Center for Joint Replacement
Multi-modal pain management- Opioid based
• Preop medications
• Intraop medications
• Continuous femoral nerve block
• Tissue infiltration
• PCA pump 24 hrs
• Post op meds
Texas Center for Joint Replacement
Goals of an Opioid Reducing Strategy
• Reduction or elimination of:
– Urinary retention
– Oversedation or respiratory depression
• Especially in patients with obstructive sleep apnea
– GI
• Post op nausea
• Constipation
– Impaired cognition
Texas Center for Joint Replacement
Walking Safety
• More alert
• No quad weakness
• Falls, TCJR – Our experience has been that falls have been a
significant issue for us using femoral nerve blocks.
– Since last quarter 2012 and so far this year 2013, we seem to have a reduction in falls since initiating our new care pathway including EXPAREL
– 2012, 14 • Last quarter 2012, 0
– 2013, YTD, 4
11/18/2013
4
Texas Center for Joint Replacement
Infiltration with long acting bupivacaine
TKR October 2012
Liposome encapsulated
Drug released 72 hrs
Texas Center for Joint Replacement
Hypothesis
Long acting bupivacaine will be as effective as a continuous femoral nerve
block Require less narcotic medication
Texas Center for Joint Replacement
Power analysis: Sample Size
• Randomly Selected Total knee patients – FNB- Dec 2011 to Sep 2012
– Exparel-Oct 2012 to Aug 2013
• Patients chosen by random number generator
• Assumed values, pilot study, literature – Expected pain scores (scale 1-10), range 3-5
– True relative treatment effect, μ1-μ2=1.5
– Expected std dev, 2.5, σ
• Sample size, 95% confidence interval, α =0.05, β=0.20, σ=2.25
• Power, 1-β= 80%
• 𝑛 = 𝑃𝐼σ
µ1 − µ2
2~ 36 in each group
11/18/2013
5
Texas Center for Joint Replacement
Prospective pain scores
• Pain scores
• Custom Pain Report EMR
• VAS, 1-10
– After PACU
• Narcotic use
– After PACU
• Number of doses
• Total narcotics
– Hydrocodone equivalents
Texas Center for Joint Replacement
Custom Pain Report
• VAS pain scores
• Corresponding pain medications
Texas Center for Joint Replacement
Total knee
Date of Surgery
POD #1, #2
11/18/2013
6
Texas Center for Joint Replacement
Preop/Intraop-Both groups
• Premeptive meds
– Lyrica 75 mg
– Oxycontin 10 mg
– Celebrex 200 mg
• OR-General anesthesia
– IV Tylenol, 1000mg
– Decadron, 8-10 mg IV
• Infiltration Cocktail
– Equivalent to 60 cc 0.25% bupiv/epi
– MS 5-10 mg
– Ketorolac 15 to 30 mg
– NS to 100 cc
Texas Center for Joint Replacement
Post op
• Continuous FNB – Pain pump, 0.2% bolus, 0.15 %
Ropiv infusion • Dose adjusted by
nursing, physical therapy • Removed day discharge
– Routine meds • Oxycontin 10 mg q 12 hr • Hydrocodone 10/3225 prn • Gabapentin 300mg tid • Toradol 15 mg IV prn
– Rescue • PCA , Dilaudid, 24 hrs • Dilaudid, IV, PO
• Long-acting bupivacaine – Exparel 20 cc, 266 mg bupiv
– Routine meds
• Meloxicam 7.5mg bid • Tramadol 50 mg q 6hr • Tylenol 1000mg po q 8hr • Gabapentin 30mg tid
– Rescue • Dilaudid, Hydrocodone rescue
Texas Center for Joint Replacement
Statistics
• Pain scores • Z-TEST
• Narcotics • WILCOXON-MANN-WHITNEY TEST
11/18/2013
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Texas Center for Joint Replacement
Results Variable Exparel FNB
n
Number of knees 38 38
Number of patients 36 36
Mean length of stay 3.83 3.97
Mean pain scores 1.82 2.29
Gender
Female 25 22
Male 11 14
Knees
Right 21 18
Left 15 20
Bilateral 2 2
Weight (kg) 93 102
Age 68 66
Texas Center for Joint Replacement
1.45
2.99
2.28 2.28 2.63
1.22
2.14 2.11 2.55 2.34
0
1
2
3
4
5
6
7
8
9
10
1 2 3 4 5
PA
IN S
CO
RES
LENGTH OF STAY IN DAYS
FNB vs Exparel
FNB Exparel
Daily Pain Scores
Texas Center for Joint Replacement
Pain scores
0
1
2
3
4
5
6
7
8
9
10
Avg. Total StayPain
Day 1 Day 2 Day 3 Day 4 Day 5
Pai
n S
core
s
Length of Stay
FNB vs Exparel
FNB Exparel
11/18/2013
8
Texas Center for Joint Replacement
Narcotic: Number of doses
14.25
3.64
4.89
3.53
2.38 1.89
7.47
4.50
1.31 1.14 0.76 0.14 0
5
10
15
20
All Rescues Day 1 Rescues Day 2 Rescues Day 3 Rescues Day 4 Rescues Day 5 Rescues
Nar
coti
c R
esc
ue
s
Length of Stay
Average Narcotic Rescues
FNB Exparel
“Scheduled or requested”
Texas Center for Joint Replacement
Hydrocodone Equivalents
FNB • Average
• 176.6 mg
Exparel • Average
• 82.2 mg
• P=00000514
0
50
100
150
200
FNB Exparel
Narcotics
Narcotics
Texas Center for Joint Replacement
Conclusions
• As part of a multi-modal program
– Long acting liposome bupivacaine infiltration gives equivalent post op analgesia compared to a continuous femoral nerve block
– BUT, with significantly less narcotic medication
11/18/2013
9
Texas Center for Joint Replacement
Infiltration with long acting liposome bupivacaine
Allows for opioid sparing analgesia Multimodal setting
Predict: This will replace traditional opioid-reliant model
Texas Center for Joint Replacement
TKR LOS
• Past 2 mo
• Average 2.8 days (3.9)
• Criteria based discharge
Texas Center for Joint Replacement
Injection technique
• 22 gauge needle, 1.5 in
• Moving needle technique
• 60 to 70 separate needle sticks
• Avoid midline posterior knee
11/18/2013
10
Texas Center for Joint Replacement
Before cementing 20-30cc
Texas Center for Joint Replacement
After cementing-capsule 20-30 cc
Texas Center for Joint Replacement
After Cementing-subQ 20-30 cc