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
Journal Title
Journal ISSN
Volume Title
Publisher
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.
Description
Keywords
Cholecystectomy