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Redefining Local Anesthetic

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Redefining Local Anesthetic Infiltration Therapy Dr. Eugene Viscusi Department of Anesthesiology Jefferson Medical College Post-operative Pain Management: Traditional ... – PowerPoint PPT presentation

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Title: Redefining Local Anesthetic


1
Redefining Local Anesthetic Infiltration Therapy
Dr. Eugene Viscusi Department of
Anesthesiology Jefferson Medical College
2
Post-operative Pain ManagementTraditional
Methods
  • Previous guidelines for post-operative analgesics
    were one size fits all -- general
    recommendations for all surgical procedures based
    on pooled data1
  • Anesthesiologists primary role in traditional
    setting2
  • Pre-operative preparation
  • Provide optimal surgical conditions
  • Minimize pain immediately after surgery

1 Kehlet, Anesthesiology Clin N Am 2005
23203-210 2 White, Kehlet, et al, Anesthesia
Analgesia 2007 1041380-1396
3
Early Changes in Post-operative Pain Management
  • Early changes in therapy included
  • 1985 Injection of bupivacaine following wound
    closure patient free of pain for 11.5
    hours1
  • 1985 First acute pain services established in
    the US and Germany2
  • 1990 Balanced analgesia used to prevent
    post-operative pain in colorectal
    surgery3
  • 1997 Kehlet introduces multimodal concept for
    post-operative care4
  • Early clinical guidelines for post-operative pain
  • 2001 US Veterans Health Administration5

1 Porter, Davis, An Royal Coll Surgeons Eng 1985
67 293-294. 2 Werner, Soholm, et al Anesth Analg
2002 951361-72. 3 Dahl, Rosenberg, et al, Br J
Anes 1990 64581-520. 4 Kehlet, Bri J Anes
199778606-617. 5 www.oqp.med.va.gov/cpg/PAIN/PAI
N_about.doc Accessed 10-116-08
4
Suboptimal Management of Post-operative Pain
Patients worst pain
Pain can be relieved effectively in 90 of
patients, but is not relieved effectively in 80
of patients.
Warfield CA, Kahn CH. Anesthesiology.
1995831090-1904. Apfelbaum JL, Chen C, Mehta
SS, Gan TJ. Anesth Analg. 200397534-540.
5
Multimodal Management of Post-operative Pain
  • Definition Multimodal (balanced) anesthesia
    involves use of two or more analgesic agents with
    different mechanisms of action to achieve optimal
    analgesic effect by additive or synergistic
    effects.1,2
  • Pain neurobiology is a complex of dynamic
    interrelated systems. Unimodal analgesia cannot
    be sufficient to provide optimal pain management.
    Additive and synergistic effects of multiple
    modes should improve outcomes. Hamed Umedaly,
    MD3

1 White, Kehlet, et al, Anesthesia Analgesia
2007 1041380-1396 2 European Society of Regional
Anaesthesia and Pain Therapy, post-operative Pain
ManagementGood Clinical Practice. 3 Umedaly,
Multimodal Perioperative Pain Management and
Multimodal Strategies to Enhance Post Operative
Outcomes. http//www.phsa.ca/NR/rdonlyres/C879B32
8-3259-4753-BD39- 3E2C22408FCA/15620/9Multimodal
PerioperativePainDrHamedUmedaly1.pdf. Accessed
10-16-2008
6
Multimodal and Multi-Disciplinary Approach
Controlling post-operative physiology
Pre-operative information Attenuation
Pain Exercise Enteral Growth and
teaching of stress relief
nutrition factors
Reduced morbidity and accelerated convalescence
Adapted from graph Kehlet, Bri J of Anes 1997
78614
7
Multimodal Management of Post-operative Pain
  • Post-operative issues
  • Pain management
  • Nausea and Vomiting
  • Ileus and constipation
  • PT
  • Pre-operative issues
  • Risk stratification
  • Anesthetic and analgesic plan
  • Intra-operative issues
  • Local anesthesia
  • Infiltration
  • Regional anesthesia
  • IV regional, peripheral nerve blocks, neuraxial
    blocks
  • General anesthesia

8
Benefits of Multimodal Pain Management
  • Benefits
  • Reduced morbidity
  • Enhanced post-operative recovery of organ
    functions
  • Accelerated convalescence1
  • Reduction of opioid use
  • Reduced doses of each analgesic
  • Improved antinociception due to
    synergistic/additive effects
  • Reduction in severity of side effects2

1 Kehlet, Bri J Anes 199778606-617. 2 Umedaly,
Multimodal Perioperative Pain Management and
Multimodal Strategies to Enhance Post Operative
Outcomes. http//www.phsa.ca/NR/rdonlyres/C879B32
8-3259-4753-BD39- 3E2C22408FCA/15620/9Multimodal
PerioperativePainDrHamedUmedaly1.pdf. Accessed
10-16-2008.
9
Post-operative Pain ManagementCurrent Practice
  • Multidisciplinary pain management team
  • Surgeon
  • Anesthesiologist
  • Pain nurse
  • Pharmacist
  • Physical therapist/occupational therapist
  • Floor nurse

White, Kehlet, et al, Anesthesia Analgesia
2007 1041380-1396
10
New Clinical Guidelines for post-operative Pain
  • Need for new guidelines
  • US Veterans Health Administration- no updates
    since 20011
  • Growing evidence that the efficacy of analgesic
    agents differs between surgical procedures2
  • Current post-operative pain management is not
    optimal
  • prospect Procedure-Specific post-operative Pain
    Working Group is a collaboration of international
    anesthesiologists and surgeons
  • New prospect guidelines include
  • Procedure-specific evidence from review of
    literature
  • Transferable evidence from other surgical
    procedures
  • Guidelines specific to each surgical procedure
  • Recommendations to support clinical decisions
  • Web-based data, quick and easy to access

1 www.oqp.med.va.gov/cpg/PAIN/PAIN_about.doc
Accessed 10-16-08 2 Gray, Kehlet, er al. Br J
Anaesth 2005 94 (6) 71014. 3 prospect web
site www.postoppain.org. Accessed 10-16-2008.
11
Looking Ahead in Post-operative Pain Management
  • Expansion of anesthesiologists role
  • Identify pre-operative risk factors
  • Develop multimodal non-opioid analgesic regimens
  • Outreach services to physical therapy/occupational
    therapy
  • Practice changes
  • Pre-operative conditioning for patients
  • aerobic and resistance exercises 3-4 weeks prior
    to surgery
  • Intensified nurse-based preoperative patient
    education
  • Multi-disciplinary approaches before and after
    surgery

White, Kehlet, et al, Anesthesia Analgesia 2007
1041380-1396
12
Post-operative Pain Control with
Extended-Release Bupivacaine Formulation After
Hernia Repair
  • Current results from a Phase IIb, multicenter,
    double-blind, parallel-group, placebo controlled
    dose-finding trial
  • SABER delivery system consists of a sucrose
    acetate isobutyrate (SAIB) solvent with which the
    drug is mixed
  • - POSIDUR(SABER-Bupivacaine) 5.0 mL
    significantly improved mean pain intensity AUC on
    movement compared with placebo post-surgery for
    48 and 72 hours
  • - Patients treated with SABER-Bupivacaine 5.0 mL
    required significantly less opioid rescue
    medications post-operatively compared with
    placebo
  • - Over the study period, SABER-Bupivacaine 5.0 mL
    prolonged the time to first opioid use compared
    with placebo.

Nicholson, Brown, et al American Hernia Society,
2008 Abstract
13
Extended-Release Liposomal Formulation of
Bupivacaine for Post-Operative Pain Management
after Hernia Repair Surgery
  • Materials and Methods
  • This is a Phase 2, double-blind study, in which
    41 patients were randomized within sequential
    cohorts to receive either DepoBupivacaine (175
    mg in Cohort 1, 225 mg in Cohort 2) or
    bupivacaine 100 mg
  • The study drug was administered via surgical
    wound infiltration, in a 40-mL total injection
    volume
  • Supplemental use of analgesics administered as
    needed after surgery and pain scores measured
    on a 0-100 mm visual analog scale (VAS) were
    recorded for 96 hours post-dose
  • Wound healing scores (0-100 mm VAS) and adverse
    events (AE) were used to monitor drug safety
  • The study has a dose-escalation design and is
    currently ongoing
  • Preliminary data from the first two cohorts are
    reported

Presented ASRA 31st Annual Regional Anesthesia
Meeting Workshops, Rancho Mirage, California
April 7, 2006.
14
Results - Safety
  • There were no deaths in the study and no patients
    were discontinued because of adverse events
  • The incidence of local and systemic AEs was
    comparable across treatment groups and did not
    appear treatment- or dose-related
  • There was only one serious adverse event (SAE) in
    the study reported in the DepoBupivacaine 225-mg
    group, which was noted as "Post-Operative
    Hematoma" and required overnight hospitalization
    for observation
  • This SAE was considered not related to the
    study drug and resolved in two days without other
    intervention.
  • Mean wound healing scores were 86.5 (SD15.8),
    89.4 (SD11.9), and 79.8 (SD14.27) in the
    DepoBupivacaine 175-mg, DepoBupivacaine 225-mg,
    and bupivacaine 100-mg groups, respectively
    (where 0worst healing and 100best healing)

Presented ASRA 31st Annual Regional Anesthesia
Meeting Workshops, Rancho Mirage, California
April 7, 2006.
15
Results - Efficacy
  • The proportion of patients requiring supplemental
    opioid medication for POP management was higher
    in the bupivacaine group (59) compared with any
    of the DepoBupivacaine groups (25)
  • Pain intensity scores at rest (VAS-R) and
    particularly with activity (VAS-A) were lower for
    the DepoBupivacaine groups
  • To assess pain intensity with activity, patients
    were asked to take a deep breath and cough
    forcefully
  • Differences in VAS-A scores were statistically
    significant (95 confidence intervals) at 4, 8,
    12, and 24 hours for DepoBupivacaine 175-mg dose
    and at 8, 12, and 24 hours for DepoBupivacaine
    225-mg dose, compared to the bupivacaine group
  • There were no clear differences between study
    groups regarding the time from the end of surgery
    to the first administration of supplemental pain
    medication

Presented ASRA 31st Annual Regional Anesthesia
Meeting Workshops, Rancho Mirage, California
April 7, 2006.
16
Pain Intensity with Activity (VAS-A)
100
bupivacaine 100 mg
DepoBupivacaine 175 mg
DepoBupivacaine 225 mg
80
60
VAS-A (0 - 100 mm)
40
20
0
4
8
12
24
48
72
96
Time (hr)
Presented ASRA 31st Annual Regional Anesthesia
Meeting Workshops, Rancho Mirage, California
April 7, 2006.
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