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 Methods.

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Redefining Local Anesthetic Infiltration Therapy

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Redefining local anesthetic infiltration therapy

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


Redefining local anesthetic infiltration therapy

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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