University Clinic Centre of Medical University of Warsaw
Warsaw, 02-091, Poland
NCT Number: NCT03886896
Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.
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Notify Me18 month–18 year
All sexes
Interventional
Phase 4
Warsaw, 02-091, Poland
Postoperative pain in children is still one of the most under diagnosed and under treated medical problems. It affects post-surgery recovery, mortality and morbidity, limits mobility. Untreated pain not only causes child's suffering but can decrease the pain threshold in the future or lead to the development of chronic pain. Postoperative analgesia has been traditionally based on opioids but as their use can be associated with adverse effects prolonging hospital stay and affecting recovery current guidelines focus on multimodal approaches involving numerous analgesics with different mechanism of action. Growing evidence suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids. Lidocaine has been proved to have analgesic and anti-inflammatory properties. It is also a potent peripheral nervous system modulator inhibiting peripheral and central sensitization. The studies performed in adult population have proved the efficacy of systemic lidocaine in postoperative pain treatment. It is an effective adjunct that reduces opioids consumption and facilitates pain management. As such lidocaine infusion has been included in postoperative pain management guidelines for adults. Studies on children population have promising results but high quality randomized controlled trials are still missing.
The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane) in reducing opioids consumption and facilitating postoperative pain control in children undergoing laparoscopic appendectomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lidocaine infusion during surgery
Other names: Intravenous lidocaine infusion
Time frame: 24 hours after surgery
Total nalbuphine requirement in milligrams during the first 24 hours after surgery
Time frame: Intraoperative - from induction of anesthesia to extubation
Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Time frame: Intraoperative - from induction of anesthesia to extubation
Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Time frame: 24 hours after surgery
Time to first dose of nalbuphine - pain score > 3 points. Assessing Face - Legs - Activity - Crying - Consolability Scale/Numerical Rating Scale/Visual Analog Pain Scale depending on participant's age.
Time frame: 24 hours after surgery
Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting > 1/hr
Time frame: 24 hours after surgery
Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
Medical University of Warsaw
Other
Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.
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