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

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slide1

Redefining Local Anesthetic

Infiltration Therapy

Dr. Eugene Viscusi

Department of Anesthesiology

Jefferson Medical College

post operative pain management traditional methods
Post-operative Pain Management:Traditional Methods
  • Previous guidelines for post-operative analgesics were “one size fits all” -- general recommendations for all surgical procedures based on pooled data1
  • Anesthesiologist’s primary role in traditional setting2
    • Pre-operative preparation
    • Provide optimal surgical conditions
    • Minimize pain immediately after surgery

1 Kehlet, Anesthesiology Clin N Am 2005 23:203-210

2 White, Kehlet, et al, Anesthesia & Analgesia 2007 104:1380-1396

early changes in post operative pain management
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 Veteran’s Health Administration5

1 Porter, Davis, An Royal Coll Surgeons Eng 1985; 67: 293-294.

2 Werner, Soholm, et al Anesth Analg 2002; 95:1361-72.

3 Dahl, Rosenberg, et al, Br J Anes 1990; 64:581-520.

4 Kehlet, Bri J Anes 1997;78:606-617.

5 www.oqp.med.va.gov/cpg/PAIN/PAIN_about.doc Accessed 10-116-08

suboptimal management of post operative pain
Suboptimal Management of Post-operative Pain

Patient’s 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. 1995;83:1090-1904. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Anesth Analg. 2003;97:534-540.

multimodal management of post operative pain
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 104:1380-1396

2 European Society of Regional Anaesthesia and Pain Therapy, post-operative Pain Management—Good Clinical Practice.

3Umedaly, Multimodal Perioperative Pain Management and Multimodal Strategies to Enhance

Post Operative Outcomes. http://www.phsa.ca/NR/rdonlyres/C879B328-3259-4753-BD39-

3E2C22408FCA/15620/9MultimodalPerioperativePainDrHamedUmedaly1.pdf. Accessed

10-16-2008

multimodal and multi disciplinary approach
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; 78:614

multimodal management of post operative pain1
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

Multimodal Management of Post-operative Pain
  • Post-operative issues
    • Pain management
    • Nausea and Vomiting
    • Ileus and constipation
    • PT
benefits of multimodal pain management
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 1997;78:606-617.

2Umedaly, Multimodal Perioperative Pain Management and Multimodal Strategies to Enhance

Post Operative Outcomes. http://www.phsa.ca/NR/rdonlyres/C879B328-3259-4753-BD39-

3E2C22408FCA/15620/9MultimodalPerioperativePainDrHamedUmedaly1.pdf. Accessed

10-16-2008.

post operative pain management current practice
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 104:1380-1396

new clinical guidelines for post operative pain
New Clinical Guidelines for post-operative Pain
  • Need for new guidelines
    • US Veteran’s 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): 710–14.

3 prospect web site: www.postoppain.org. Accessed 10-16-2008.

looking ahead in post operative pain management
Looking Ahead in Post-operative Pain Management
  • Expansion of anesthesiologist’s 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 104:1380-1396

post operative pain control with extended release bupivacaine formulation after hernia repair
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

slide13
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.

results safety
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 (SD=15.8), 89.4 (SD=11.9), and 79.8 (SD=14.27) in the DepoBupivacaine 175-mg, DepoBupivacaine 225-mg, and bupivacaine 100-mg groups, respectively (where 0=worst healing and 100=best healing)

Presented: ASRA 31st Annual Regional Anesthesia Meeting & Workshops, Rancho Mirage, California April 7, 2006.

results efficacy
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.

pain intensity with activity vas a
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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