Nebulized analgesia during laparoscopic appendectomy (NALA): A randomized triple-blind placebo controlled trial

J Pediatr Surg. 2019 Jan;54(1):33-38. doi: 10.1016/j.jpedsurg.2018.10.029. Epub 2018 Oct 5.

Abstract

Purpose: Postoperative pain remains a considerable concern for patients and families. We assessed whether nebulized ropivacaine reduces morphine consumption and pain after laparoscopic appendectomy for uncomplicated appendicitis in children.

Methods: Patients 7-17 years old with uncomplicated appendicitis were randomized to ropivacaine (intervention arm) or saline nebulization (placebo arm) at the onset of laparoscopy. Nonconsenting individuals were treated with standard care and invited to provide clinical data (baseline arm). The primary outcome was in-patient morphine utilization. Secondary outcomes included pain scores at multiple time-points, markers of recovery, operative times, and surgeon satisfaction. The trial was registered (NCT02624089).

Results: Study enrollment was 116 patients over a 1-year period: Intervention (n = 43), Placebo (n = 39), Baseline (n = 34). No differences in baseline characteristics were noted between groups. No difference was noted in overall in-patient morphine consumption between randomized groups (0.31 vs. 0.35 mg/kg, p = 0.42) or between ropivacaine and baseline (0.31 vs. 0.277 mg/kg, p = 0.62). Although operative times were comparable between groups, 63% of surgeon respondents felt that nebulization obscured visualization.

Conclusion: Nebulized ropivacaine did not reduce postoperative morphine consumption or pain scores after laparoscopic appendectomy for simple appendicitis in children. Given that it decreases visualization and likely increases costs, nebulized administration of intraperitoneal analgesia does not appear warranted in this context.

Type of study: Treatment study.

Level of evidence: Level I.

Keywords: Appendicitis; Pain.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Analgesia / methods*
  • Analgesics, Opioid / administration & dosage
  • Anesthetics, Local / administration & dosage*
  • Appendectomy / adverse effects*
  • Canada
  • Child
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Laparoscopy / adverse effects*
  • Male
  • Morphine / administration & dosage
  • Nebulizers and Vaporizers
  • Operative Time
  • Pain Measurement
  • Pain, Postoperative / drug therapy*
  • Personal Satisfaction
  • Prospective Studies
  • Ropivacaine / administration & dosage*
  • Treatment Outcome

Substances

  • Analgesics, Opioid
  • Anesthetics, Local
  • Morphine
  • Ropivacaine

Associated data

  • ClinicalTrials.gov/NCT02624089