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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 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Average Length of Stay 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

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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

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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

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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

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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

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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

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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

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Texas Center for Joint Replacement

Thank you