EXPAREL FOR PLANE & PERIPHERAL NERVE BLOCKS

KIMBERLY WESTRA CRNA, DNP, MS, MBA

WHAT IS EXPAREL?

• EXPAREL IS A LONG ACTING SUSTAINED RELEASE FORMULATION OF BUPIVACAINE HCL

• EXPAREL WAS FORMULATED USING A DEPOFOAM TECHNOLOGY THAT ENCAPSULATES THE BUPIVACAINE IN MULTIVESICULAR LIPOSOMAL PARTICLES WHICH IS RELEASED OVER TIME WITHOUT ALTERING THE DRUG MOLECULE ITSELF

EXPAREL DOSING

• EXPAREL AVAILABLE IN 10 ML & 20ML VIALS WITH 13.3MG/ML CONSISTENT CONCENTRATIONS

• 266MG/20ML EXPAREL VIAL

• 133MG/10ML EXPAREL VIAL

EXPAREL INFILTRATION, EXPANSION DILUTION

EXPAREL SAFETY

• EXPAREL VIAL ONCE OPENED SHOULD BE USED WITHIN 4 HOURS DUE TO RISK OF INFECTION & BREAKDOWN OF LIPOSOMAL LAYERS

• CLOUDLY APPEARANCE MAY BE CONFUSED WITH PROPOFOL, CAUTION FOR MEDICATION HANDLING

EXPAREL SAFETY CONCERNS

EXPAREL SHOULD NOT BE MIXED OR DILUTED WITH:

NON BUPIVACAINE LOCAL ANESTHETICS INCLUDING LIDOCAINE CAN CAUSE RAPID RELEASE OF BUPIVACAINE DUE TO DISRUPTION OF DEPOFOAM ENCAPSULATION

LIDOCAINE & OTHER NON BUPIVACAINE LOCALS SHOULD NOT BE ADMINISTERED FOR A MINIMUM OF 20 MINUTES

EXPAREL & SAFETY CONCERNS

• EXPAREL SHOULD NOT BE MIXED WITH WATER OR OTHER HYPOTONIC AGENTS AS IT WILL DISRUPT LIPOSOMAL PARTICLES

• EXPAREL MAY BE MIXED WITH STERILE INJECTABLE NORMAL SALINE

EXPAREL SAFETY CONCERNS

• EXPAREL MAY BE INJECTED WITH BUPIVACAINE BY MUST NOT EXCEED A 2:1 RATIO (EXPAREL 2MG FOR EACH BUPIVACAINE 1MG). CAN BE COMBINED IN SAME SYRINGE

• PHARMACOKINETICS MAY BE ALTERED WHEN COMBINING EXPAREL & BUPIVACAINE

LOCAL TOXICITY TABLE

EXPAREL

• TOXIC EFFECTS ARE ADDITIVE & ADMINISTRATION SHOULD BE MONITORED FOR CARDIOVASCULAR & NEUROLOGICAL SIDE EFFECTS STANDARD MONITORING EQUIPMENT WITH LIPID RESCUE/RESUSCITATION EQUIPMENT NEARBY

• TOPICAL ANTISEPTICS SHOULD BE ALLOWED TO DRY PRIOR TO INJECTION OF EXPAREL TO AVOID ALTERATION IN LIPOSOMAL DELIVERY SYSTEM, RAPID RELEASE OF BUPIVACAINE MOLECULES

EXPAREL ADVERSE REACTIONS

• CARDIOVASCULAR REACTIONS

• NEUROLOGICAL REACTIONS

• ALLERGIC REACTIONS

• CHONDROLYSIS

• ACCIDENTAL INTRAVASCULAR REACTION

EXPAREL CONTRAINDICATION

• CONTRAINDICATED FOR PATIENTS WITH BUPIVACAINE OR AMIDE ALLERGIES

• CONTRAINDICATED IN PARACERVICAL BLOCK FOR OBSTETRICAL PATIENTS, RESULTED IN FETAL BRADYCARDIA & DEATH.

EXPAREL SAFETY CONCERNS

• EXPAREL AS AN AMIDE IS METABOLIZED BY THE LIVER AND SHOULD BE USED WITH CAUTION FOR PATIENTS WITH IMPAIRED LIVER FUNCTION INCREASED RISK OF TOXICITY & SIDE EFFECTS

EXPAREL SAFETY CONCERNS

• CARDIOVASCULAR REACTIONS: DEPRESSION OF CARDIAC CONDUCTION, VENTRICULAR ARRYTHMIAS, AV BLOCK, DEPRESSION OF MYOCARDIAL CONTRACTILITY WITH PERIPHERAL VASODILATION

EXPAREL SAFETY CONCERNS

• NEUROLOGICAL REACTIONS:

CHARACTERIZED BY EXCITATION THEN DEPRESSION OR IMMEDIATE NEUROLOGICAL DEPRESSION: RESTLESSNESS, DIZZINESS, TINNITUS, BLURRED VISION, TREMORS, SEIZURES, CARDIOVASCULAR INSTABILITY, DEATH

EXPAREL

• EXPAREL VIAL MUST BE GENTLY AGITATED TO RESUSPEND THE PARTICLES PRIOR TO WITHDRAW

• USE 25G NEEDLE OR LARGER TO INJECT EXPAREL TO MAINTAIN THE LIPOSOMAL STRUCTURE

• AVOID ANY ADDITIONAL LOCALS FOR 96 HOURS FOLLOWING EXPAREL (EXPAREL ALERT BRACELET)

EXPAREL & ORTHOPEDICS• ORIGINAL FDA APPROVAL OF EXPAREL FOR

BUNIONECTOMY & HEMORRHOIDECTOMY SINCE THIS TIME ADDITIONAL APPROVALS FOR PERIPHERAL BLOCKS WITH POSSIBLE FUTURE APPROVALS: STUDIES ONGOING

• NEW APPROVALS FOR INTERSCALENE BLOCK AND LOCAL POST SURGICAL PAIN RELIEF IN APRIL 2018 NOW INCREASING POPULARITY OF USE IN ORTHOPEDIC UPPER EXTREMITY PROCEDURES

• PILLAR STUDY 2018: TOTAL KNEE REPLACEMENTS LOOKING AT EXPAREL AS PAIN MANAGEMENT OPTION FOR TKR (JANUARY 2018, JOURNAL OF ARTHROPLASTY)

EXPAREL: EMERGING USES• EMERGING USES: ABDUCTOR CANAL BLOCK

(ACB)

• CURRENT CLINICAL TRIAL FOR EFFECTIVENESS OF ADDUCTOR CANAL BLOCK FOR TKR. LATE 2019 START DATE NOT YET RECRUITING. NCT04003506

• BELSH ET AL (2018) RANDOMIZED DOUBLE BLIND CONTROLLED TRIAL COMPARING EXPAREL VS. ROPIVACAINE “PAIN BALL” FOR PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY (TKA)

EXPAREL: EMERGING USES

• EXPAREL & ADDUCTOR CANAL BLOCK: BELSH ET AL 2018: EXPAREL VS ROPIVACAINE TKA

• VAS PAIN SCORES LOWER EXPAREL P = 0.00052

• REDUCE OPIOID USE: EXPAREL VS ROPIVACAINE P = 0.02

• DISTANCE OF AMBULATION DAY 2 & RANGE OF MOTION: EXPAREL VS ROPIVACAINE P VALUE = 0.018

• LENGTH OF STAY SIMILAR IN BOTH GROUPS

EXPAREL & ADDUCTOR CANAL BLOCK

• WANG ET AL 2016 COMPARED SINGLE CENTER, RETROSPECTIVE MATCHED COHORT STUDY FOR TKA USING EXPAREL VS. ROPIVACAINE PAIN BALL

• RESULTS: EXPAREL GROUP HAD SIGNIFICANTLY LOWER MEAN PAIN SCORE AS COMPARED TO ROPIVACAINE P = 0.001 FOR 35 HOURS TO 72 HOUR MARKER, LENGTH OF STAY SIMILAR

EXPAREL & ADDUCTOR CANAL BLOCK

• LANKRA ET AL 2019 MATCHED COHORT STUDY ACB WITH EXPAREL ADMIXED WITH .25% BUPIVACAINE VS .25% BUPIVACAINE FOR TKA FOR PATELLAR PERIARTICULAR INJECTION. ALL PATIENTS RECEIVED A PREOPERATIVE “COCKTAIL” OF TYLENOL, CELECOXIB, GABAPENTIN & SCOPOLAMINE PATCH POST AURICULAR. POSTOPERATIVELY, TYLENOL, KETOROLAC, CELECOXIB, GABAPENTIN, ORAL OPIOIDS AS NEEDED, IV HYDROMORPHONE FOR BREAKTHROUGH PAIN

• RESULTS:

• PAIN SCORES IMPROVED ESPECIALLY ON POD 2 & 3 FOR EXPAREL

• HIGHER NUMBER OF FEET WALKED ON POD 1 & 2

• REDUCED MORPHINE NEED FOR BREAKTHROUGH PAIN ON FLOOR ESPECIALLY POD 1 & 2

ADDUCTOR CANAL BLOCK & EXPAREL

HTTPS://WWW.YOUTUBE.COM/WATCH?V=AIW_RQRKPNW

EXPAREL & INTERSCALENE BLOCK: FDA APPROVED• PATEL ET AL 2019 MULTICENTER RANDOMIZED

DOUBLE BLINK COMPARING EXPAREL VS PLACEBO FOR TOTAL SHOULDER ARTHROPLASTY OR ROTATOR CUFF REPAIR. ALL PATIENTS RECEIVED ORAL OR IV TYLENOL, LOW DOSE ASPIRIN. THE FOLLOWING WERE PROHIBITED IN STUDY PARTICIPANTS: LONG ACTING OPIOIDS, DEXMEDETOMIDINE WITHIN 3 DAYS, SYSTEMIC GLUCOCORTICOIDS WITHIN ONE MONTH, PREGABALIN, SEROTONIN UPTAKE INHIBITORS, GABAPENTIN, DULOXETINE

• RESULTS:

• PAIN SCORES LOWER IN EXPAREL GROUP P = .0001

• EXPAREL REDUCED OPIOID CONSUMPTION AT 0-48 HOURS P = .0001

• OPIOID FREE SUBJECTS THROUGH 48HRS. EXPAREL GROUP 9 VS. 1 IN THE PLACEBO GROUP P = .008

EXPAREL & INTERSCALENE BLOCK

• VANDEPITTE ET AL 2018 BLINDED, RANDOMIZED TRIAL COMPARING EXPAREL ADMIXED WITH 0.25% BUPIVACAINE VS. 0.25% BUPIVACAINE FOR INTERSCALENE BLOCK (ISB)

• ALL PATIENTS RECEIVED THE FOLLOWING:

• PREOP: IV TYLENOL 1 GM

• KETOROLAC 0.5MG/KG MAX DOSE 30MG

• DEXAMETHASONE 5MG

• POST OP: PO TYLENOL 1GM, P0 IBUPROFEN 400MG

• DEXAMETHASONE 5MG Q 24 X 48 HOURS

• SUBLINGUAL TRAMADOL 50MG Q 4 HOURS FOR BREAKTHROUGH PAIN

EXPAREL & INTERSCALENE BLOCK

• VANDPITTE 2018: ALTERNATIVE PAIN SCORE RATING “WORST PAIN” SCORE & PATIENT SATISFACTION WITH PAIN TREATMENT, SENSORY & MOTOR FUNCTION, OPIOID CONSUMPTION, TIME TO REQUEST

• RESULTS: EXPAREL GROUP SHOWED SIGNIFICANTLY LOWER “WORST” PAIN SCORE IN FIRST WEEK VS. BUPIVACAINE GROUP P = .0001 FUNCTIONALITY/MOTOR & SENSORY CHARACTERISTICS SIMILAR OPIOID TIME TO REQUEST & CONSUMPTION IN MG TRAMADOL SIMILAR

EXPAREL & INTERSCALENE BLOCK

• HTTPS://WWW.YOUTUBE.COM/WATCH?V=DG9BJ-32YLC

EXPAREL COST CONCERNS

• EXPAREL COST CONCERNS MUST BE CONSIDERED WHEN INTEGRATING & PLANNING THE UTILIZATION INTO THE BLOCK SERVICE OF ANY PAIN MANAGEMENT TEAM

• EXPAREL COST AVERAGE $280-300 VERSUS BUPIVACAINE COST $2-5

• NEW BILLING CODES FOR AMBULATORY CENTERS FOR EXPAREL 2019: C9290

• COST TO PATIENT VARIES DEPENDING UPON INSURANCE PLAN, TYPE OF FACILITY, PLAN COVERAGE SPECIFICS

EXPAREL & INTERSCALENE BLOCK

• EXPAREL APPROVED BY FDA 2018 FOR USE FOR ISB INTENDED FOR PAIN RELIEF FOR 48 TO 72 HOURS INCREASING USE OF EXPAREL FOR UPPER EXTREMITY: SHOULDER PROCEDURES

EXPAREL & SINGLE DOSE INFILTRATION FOR POST SURGICAL ANALGESIA

• EXPAREL FOR SINGLE INJECTION POST SURGICAL ANALGESIA APPROVED FOR TAP BLOCK STUDIES EXAMINE OBSTETRICAL PROCEDURES-CESAREAN SECTIONS, ABDOMINAL SURGERY.

• RETROSPECTIVE REVIEWS FOR SINGLE DOSE INFILTRATION OFFERING NEW DATA FOR EFFICACY OF EXPAREL ACROSS DISCIPLINES, PROCEDURES

• INCREASED AREA FOR RESEARCH: RETROSPECTIVE CHART REVIEWS, DOUBLE BLIND STUDIES.

EXPAREL & TAPS BLOCKS FOR CESAREAN DELIVERY

• W. BAKER ET AL 2018 JOURNAL OF PAIN RESEARCH

• RETROSPECTIVE CHART REVIEW OF 201 CESAREAN DELIVERIES: 101 EXPAREL TAPS INJECTIONS VS. 100 NON TAPS INJECTION

• EXAMINED PAIN, OPIOID CONSUMPTION, LENGTH OF STAY, PACU STAY LENGTH, TIME TO AMBULATION

EXPAREL & TAPS FOR CESAREAN DELIVERY

• RESULTS BAKER ET AL 2018 IN JOURNAL OF PAIN RESEARCH:

• EXPAREL TAPS VS. NON EXPAREL NON TAPS

• EXPAREL REDUCED OPIOID USE 42% WITH P<0.001

• EXPAREL REDUCED PAIN SCORES 40% P<0.001

• EXPAREL REDUCED LOS 2.9 DAYS VS 3.6 DAYS P=0.006

EXPAREL & TAPS CESAREAN DELIVERY

• EXPAREL SIGNIFICANTLY REDUCED TIME TO AMBULATION 39% P<0.01

• EXPAREL REDUCED PACU CRITERIA DISCHARGE READY TIMES 138 MINUTES VS. 168 MINUTES P<0.028

• EXPAREL NOT FDA APPROVED FOR USE IN PREGNANCY BLOCK PERFORMED POST SURGICAL PROCEDURE:

• EXPAREL NOT FDA APPROVED FOR USE IN PATIENTS UNDER 18 YEARS OLD

TRANSVERSE ABDOMINAL PLANE BLOCK & EXPAREL

• SHAKER ET AL 2018 PROSPECTIVE OPEN RANDOMIZED CONTROL TRIAL EXPAREL VERSUS TRANSVERSE ABDOMINAL PLANE BLOCK VS. THORACIC EPIDURAL CATHETER PLACED AT T7 LEVEL WITH BUPIVACAINE & FENTANYL INFUSION FOR UPPER ABDOMINAL PROCEDURES

EXPAREL FOR UPPER ABDOMINAL PROCEDURES

• SHAKER RESULTS 2018

• EXPAREL TAPS BLOCK GROUP USED SIGNIFICANTLY LESS OPIOIDS ON POD 0 THROUGH POD 3. P > .0001 EXPAREL GROUP SAW LESS HYPOTENSION ON POSTOP DAY 1 AS COMPARED TO THE THORACIC EPIDURAL CATHETER GROUP

• NOTE DERMATOME COVERAGE IN DIAGRAM

SUBCOSTAL TAP BLOCK & EXPAREL

• HUTCHINS ET AL 2018: PROSPECTIVE, RANDOMIZED CONTROL, OBSERVER BLINDED STUDY. COMPARED EXPAREL TO 0.25 % BUPIVACAINE WITH EPINEPHRINE 1:200,000 FOR LAPAROSCOPIC HAND ASSISTED DONOR NEPHRECTOMY

EXPAREL FOR LAPAROSCOPIC HAND ASSISTED NEPHRECTOMY: SUBCOSTAL TAPS

• HUTCHINS 2018 RESULTS SUBCOSTAL TAPS:

• EXPAREL GROUP LESS PAIN ESPECIALLY AT 24-48 HOURS AS COMPARED TO BUPIVACAINE GROUP P = 0.0009

• EXPAREL GROUP HAD A SHORTER LENGTH OF STAY MEDIAN NUMBER OF DAYS P = 0.02 AS COMPARED TO THE 0.25% BUPIVACAINE FOR SUBCOSTAL TAPS BLOCK

TAPS & EXPAREL• HUTCHINS ET AL 2019:

RANDOMIZED, DOUBLE BLINDED PLACEBO-CONTROLLED STUDY IN WOMEN FOR ROBOTIC OR LAPAROSCOPIC ASSISTED HYSTERECTOMY. EXPAREL WITH BUPIVACAINE 0.25% WITH EPINEPHRINE 1:200,000 VIA TAPS BLOCK VS. PORT SITE INJECTION WITH 0.25% BUPIVACAINE WITH EPINEPHRINE 1:200,000

EXPAREL & TAPS BLOCK• HUTCHINS 2019: RESULTS

LAPAROSCOPIC & ROBOTIC HYSTERECTOMY HAD EXPAREL GROUP HAD REDUCED OPIOID CONSUMPTION AT 72 HOURS IN EXPAREL GROUP P = .034 AS COMPARED TO 0.25% BUPIVACAINE TO PORT SITE INJECTION

• EXPAREL GROUP ALSO DEMONSTRATED A LOWER MAXIMUM PAIN SCORE AT 72 HOURS P =.022 AS COMPARED TO THE 0.25% BUPIVACAINE PORT SITE INJECTION

TRANSVERSE ABDOMINUS PLANE BLOCK

EXPAREL, NERVE BLOCKS, ULTRASOUND

• BLOCK AREA MUST INCLUDE:

• MONITORING EQUIPMENT, RESUSCITATION SETUP, LIPID RESCUE PROTOCOL SUPPLIES, COMMUNICATION TOOL/ALERT SYSTEM, ULTRASOUND DEVICE, STANDARDIZED BLOCK SUPPLY CART, TRAINED ASSISTANT FOR BLOCK PROCEDURES

EXPAREL BLOCKS & ULTRASOUND

• ANESTHESIA PROVIDERS SHOULD ENSURE PROFICIENCY WITH USE OF ULTRASOUND TO OPTIMIZE ACCURACY OF BLOCK & DECREASE RISK OF ADVERSE EVENTS. USE OF NERVE STIMULATOR/STIMUPLEX NO LONGER STANDARD OF CARE

ULTRASOUND BASICS

• HTTPS://WWW.YOUTUBE.COM/WATCH?V=RSKRESAGZEC

EXPAREL IN THE ANESTHESIA PROVIDERS TOOLKIT • USE OF REGIONAL ANESTHESIA FOR

PERIPHERAL NERVE BLOCK, TRANSABDOMINAL PLANE BLOCK & SINGLE SITE LOCAL INFILTRATION WITH EXPAREL CAN REDUCE OPIOID REQUIREMENTS, IMPROVE PAIN SCORES AND BECOME AN INTEGRAL COMPONENT OF A MULTIMODAL ANESTHESIA PLAN OF CARE.

QUESTIONS?