Download - BEIRUT-2016 ADITIVES EXPAREL
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Admir Hadzic, MD, Professor of AnesthesiologyDirector, NAICE (North American Institute for Continuing Education)Director, NYSORA (The New York School of Regional Anesthesia)Consultant, Department of Anesthesiology, Ziekenhuis Oost-Limburg, Genk, Belgium
Liposome Bupivacaine (Exparel)Current Uses and Future
Goals:• Catheters• Future: Liposome bupivacaine • Mechanism of action• Current clinical uses• Systemic and NeuroToxicity Concerns• Local tissue and Neurotoxicity• Current research
DisclosureResearch grants: GSK, Baxter, Pacira
Advisor: GE, Sonosite, BD, B Braun, LifeTech
Consultant: Pacira Pharmaceuticals
Royalty income: BBraun Medical
Avenue-V, LLC
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In an ideal world
Catheters would be
BEST analgesic solution
Problems with
Catheters?
NOStandards?
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Retained catheter with neck abscess after total shoulder replacement
Shocker
20 Lean Volunteers
US-guided FNB
Cath 3 cm beyond tip
Ambulate Q 1hr
Check Cath Tip by US
How many catheters are not in the therapeutic position after
1, 2, 3, 4, 5, 6 hrs?
25%
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Current Clinical use
FDA Approved?Soft tissue infiltration
Local Infiltration into Surgical Site
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Dasta et al., Curr Med Res Opin, 2012; 28, 1609‐15.
Dasta et al., Curr Med Res Opin, 2012; 28, 1609‐15.
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Dasta et al., Curr Med Res Opin, 2012; 28, 1609‐15.
LIA – Total Knee ReplacementBarrington et al., Am J Orth, 2013.
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Infiltration for hemorrhoidectomy(Standard anal block)
Infiltration for abdominal surgery (TAP infiltration)
=
SURGICAL SITE Hemorrhoidectomy
SURGICAL SITE abdominal wall
CAN DILUTE TO REQUIRED VOLUME
Exparel 266mg (20ml) l
Exparel 266mg + 20ml NaCl = 40ml solution
0.25% BupivacaineNo mixing with other LA (liposome stability)
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LAST Scare
Time, Hours
0 24 48 72 96
500
400
300
200
100
0
Plasm
a Bupivacaine HCl C
oncentration (ng/m
L) CNS Toxicity:2,500 to 4,000 ng/ml
PLASMA LEVEL OF EXPAREL AFTER SOFT TISSUE INJECTION
Exparel 266mg
Bupivacaine 100mg
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Inadvertent IV
Injection?
IV INJECTION in dogs
3x
CNS Toxicity:2,500 to 4,000 ng/ml
Low free bupivacaine exposure• ~ 50% remains as intact EXPAREL particles
• ~45% Bupivacaine associated with lipid fragments
• ~ 5% Free Bupivacaine
• Free bupivacaine releases slowly from liposomes after IV Injection
Inadvertent IV Injection?
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Systemic safety profile: Better than Bupivacaine
2,000,000Patient-exposures
without LAST Viscusi E, 2015 RAPM
Neurotoxicity?
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Neurologic Complications of PNBs and Toxicity of Local Anesthetics
Admir Hadzic, MD, Professor of AnesthesiologyDirector, NAICE (North American Institute for Continuous Education)Director, NYSORA (The New York School of Regional Anesthesia)Consultant, Department of Anesthesiology, Ziekenhuis Oost-Limburg, Genk, Belgium
NO Neurotoxicity!
Damjanovska M, Cvetko E, Hadzic A. Anaesthesia. 2015 Dec;70(12):1418-26
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Hadzic et al .Anesthesiology, June 2016
PAIN at REST
Hadzic et al .Anesthesiology, June 2016
PAIN w ACTIVITY
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Hadzic et al .Anesthesiology, June 2016
ABILITY TO WALK?
Plasma Levels Liposome Bupivacaine:after FNB
Hadzic et al .Anesthesiology, June 2016
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Exparel in ISB for Shoulder Sx
50 Patients Rotator Cuff or Shoulder Replacement Sx
n= 24 pts Bupivacaine 0.25%
15ml
n= 26 pts
Exparel 10ml + 5ml bupi 0.25%
All blocks preoperatively within 30 min of SurgeryAll patients received GA for surgeryOnset times, VAS scores, Sleep, Opioids
Vandepitte et al .NWAC, April 2016 (Ethics Committee ZOL, Belgium, IND – FAGG, Belgium FDA Equivalent
Vandepitte et al .NWAC, April 2016 (Ethics Committee ZOL, Belgium, IND –FAGG, Belgium FDA Equivalent
Vandepitte et al .NWAC, April 2016 (Ethics Committee ZOL, Belgium, IND – FAGG, Belgium FDA Equivalent
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Nerve BlocksNot FDA
Approved
Current Research?
Liposome Bupivacaine (Exparel)Current Uses and Future