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Length of stay after open radical prostatectomy with intravenous lignocaine followed by 24-hour subcutaneous infusion: blinded, randomized, placebo controlled multicentre trial.

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Acknowledgements

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  1. Length of stay after open radical prostatectomy with intravenous lignocaine followed by 24-hour subcutaneous infusion: blinded, randomized, placebo controlled multicentre trial Laurence WeinbergStaff Anaesthetist, Austin Hospital, Victoria Clinical Fellow, Department of Surgery, The University of Melbourne.

  2. Acknowledgements • ANZCA: Project Grant • University of Melbourne • Story D, Gordon I, Christophi C • Co-investigators • Rachbuch C, Beilby D, Trinca J, Howard W, Yeomans M, Yanezas M, • James K, McNicol L

  3. Intravenous Lignocaine • Clear advantages: abdominal surgery • Lower pain scores • Opioid sparing effects • Enhances functional recovery • Reduces immune alterations • Decreases length of hospital stay

  4. Subcutaneous Lignocaine • Neuropathic pain • Ischaemic pain Limited data for ACUTE postoperative pain

  5. Hypothesis Intraoperative IV lignocaine + 24 hrs post-operative SC lignocaine Enhances recovery Shortens length of hospital stay after open radical retropubic prostatectomy

  6. Study Design • Prospective randomised multicentre • Blinded • Inclusion criterion • Adults (age > 18 years < 75 years) • Elective open radical prostatectomy • ASA I-III patients • Exclusion criterion • Creatinine > 200 umoll/L, Abn LFT’s • Chronic opioid use • Allergy: morphine, LA • Cardiac conduction defects/Class I anti-arrhythmic agents

  7. Study Design • Human Research Ethics approval • Consenting patients randomised 2 groups • GA: standardized, no regional anaesthesia • All patients: • Induction: Propofol: 1-3 mg/kg; Fentanyl 3 ug/kg • Maintenance: Volatile anaesthesia: 0.6-1 MAC, Fentanyl infusion 2.5 ug/kg/hr • Surgical closure: Paracetamol IV 1 g, Ketorolac 30 mg • Postoperatively: Morphine PCA, 1 mg boluses, 5 min lockout QID paracetamol, NSAID, Acute Pain Service

  8. Study Design • Lignocaine group: Pre-induction • Loading dose IV: 1.5 mg/kg • Intraop infusion IV: 1.5 mg/kg/hr

  9. Study Design • Lignocaine group: • Post-op SUBCUT infusion: 1.5 mg/kg/hr

  10. Study Design • Control group: • Normal saline: equal volume delivered in the same way

  11. Study Design • Primary outcome • Length of hospital stay • Secondary outcomes • GI function • Time to mobilise • Rescue analgesia and anti-emetic therapy • Visual Analogue Scores for pain (VAS) 0 to 100mm • Morphine consumption: 24 hours • Patient satisfaction • Opioid & lignocaine side effects • Lignocaine plasma levels: PACU & 24 hours • Adverse events

  12. Statistics analyses • Power analyses: based on a PILOT STUDY* for patients undergoing open radical prostatectomy (2007/8) who received PCA morphine alone: mean hospital stay 4.5 days (SD 26.4 hrs) • Sample size: 18 hour difference in hospital stay, power 0.8, significance level of 0.05, 38 patients per group • Analyses:intention-to-treat bases * Weinberg L, et al. Anaesthesia & Intensive Care2010; 38: A1116

  13. Consort diagram Total patients consented N = 85 Inclusion critreria met N = 75 Randomised Patients excluded N = 10 Laparoscopic retropubic prostatectomy N = 9 Procedure aborted (anaphylaxis) N = 1 Lignocaine Group N = 37 Placebo Group N = 38 Intention to treat Intention to treat

  14. Demographics * Data presented as SD, range

  15. Hospital Stay

  16. Operative variables • For comparison of means, standard two-sample t-tests were used • Uses Fisher's Exact Test due to comparison of proportions with small sample size

  17. Postoperative variables • Two-sample t-test was used for the comparisons of means • For the comparison of percentages, Fisher’s exact test was used for the p-values and the Newcombe-Wilson • approximation for the confidence intervals

  18. Adverse Effects (% patients)

  19. Post-op Complications

  20. Pain Rest Difference: 18 mm 95% CI: 7.3 – 28 mm P = 0.001

  21. Cumulative Morphine Difference: 13.9 mg 95% CI: 2.2 - 25.7 P = 0.02

  22. Cumulative Morphine Difference: -0.62 95% CI: -0.14 to -0.02 P = 0.02

  23. Adverse events • SC cannulae: nil complications • Inadvertent administration of lignocaine

  24. Lignocaine Levels • * Uses Mann-Whitney of medians (adjusted for ties) due to non-Normal data • Not appropriate for formal analyses of the 24-hour data as all values in placebo were recorded as < 0.5.

  25. Conclusions IV lignocaine followed by 24-hr SC infusion • Shorter length of stay (1.3 days) • Accelerated acute rehabilitation • Free fluid (3.9 hrs) • Diet (5.4 hrs) • Mobilisation (4.6 hrs) • Less 24-hour morphine use • Lower pain scores • Safety factors: paramount

  26. Future directions • Plasma levels & pain scores • Cancer recurrence • Chronic pain • Utility in laparoscopic radical prostatectomy

  27. Thank you 谢谢

  28. Future directions Pearson’s correlation is r = 0.09 here, a weak positive correlation (P = 0.6)

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