Efficacy and safety on non-opioid based versus opioid-based multimodal analygesia in patients undergoing elective laporoscopic cholecystectomy : a randomized controlled trial

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Date
2020
Authors
Khairuddin, Khuzaimah
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Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia
Abstract
Background Laparoscopic cholecystectomy resulted in less postoperative pain and reduction in the need for analgesia compared to open cholecystectomy. However, some patients still experience moderate to severe pain for 24 hours postoperative. Non-opioid based multimodal analgesia is proven to be comparatively effective than opioid-based analgesia in reducing postoperative pain while reducing the side effects from opioid usage. Objective To determine the efficacy and safety of non-opioid based multimodal analgesia compared to standard opioid-based multimodal analgesia for postoperative pain control in elective laparoscopic cholecystectomy. Method Participants were divided equally into two groups by using computergenerated randomization. Both groups were induced with the same anaesthetic agent for induction of anaesthesia by using intravenous fentanyl 2mcg/kg ABW, intravenous propofol 2mg/kg LBW followed by sevoflurane at 1MAC in oxygen/air and intravenous Rocuronium 0.6mg/kg ABW to facilitate intubation. For intraoperative analgesic, Group A received intravenous dexmedetomidine infusion 0.5-1 mcg/kg/hour and intravenous ketamine infusion 0.125-0.25 mg/kg/min whereas group B received 0.05-0.1mg/kg morphine. Intraoperative hemodynamic fluctuation was recorded during trocar insertion, gas insufflation, and end of surgery. The visual analogue pain (VAS) were determined at 1 hour, 4 hours, 8 hours, and 12 hours postoperation. Total rescue analgesia (intravenous fentanyl) needed were compared between these two groups, and the incidence of postoperative nausea vomiting were documented. Result Overall, we analysed 30 patients in each arm receiving NOBMA and OBMA. Compared with preset noninferiority margins, the mean differences in AUC pain Score between the non-opioid analgesic group and opioid analgesic group within 12 hours was -2.15 (1-sided 97.5% CI: ∞, 1.09). The upper CI was significantly lower than the predetermined non-inferiority margin of 4 (pvalue for noninferiority=0.0002), indicating non-opioid treatment was found to be non-inferior to opioid treatment in pain relief within 12 hours in post laparoscopic Cholecystectomy. There was higher prevalence of analgesic failure (n=5,16.7%) was recorded in opioid groups patients. Nevertheless, more patients experienced pain score <4 (n=28, 93.3%) in those who received non-opioid treatment. Patients randomised to non-opioid group experienced significantly low percentage of nausea/vomiting incidence compare to opioid group within 12 hours (non opioid group=6.7% vs. opioid group=36.7%, χ= 31.8, p<0.001), indicating superiority of NOBMA for both outcomes. Hemodynamic parameter shows non-inferiority in both groups during trocar insertion, gas insufflation, and end of surgery. Conclusion Compared with OBMA, the study suggests that NOBMA provides noninferior postoperative analgesia and less for postoperative nausea vomiting in patient undergoing laparoscopic cholecystectomy.
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Cholecystectomy
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