A Phase 4 interventional study of Lidocaine in Acute Appendicitis, Postoperative Pain and Postoperative Nausea and Vomiting, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Supportive care
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.
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.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's enrollment of 74 is below the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Group A: children receiving standard general anesthesia with intravenous lidocaine infusion 1,5 mg/kg for 5 minutes before induction of anesthesia. After 5 minutes, lidocaine infusion continued at rate of 1.5 mg/kg/h during operation, and discontinued before move the patients to PACU.
Drug: Lidocaine
Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion
Lidocaine infusion during surgery
Also known as: Intravenous lidocaine infusion
Postoperative opioid consumption
Total nalbuphine requirement in milligrams during the first 24 hours after surgery
Time frame: 24 hours after surgery
Intraoperative opioid consumption
Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Time frame: Intraoperative - from induction of anesthesia to extubation
Intraoperative volatile anesthetic consumption
Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Time frame: Intraoperative - from induction of anesthesia to extubation
Time to first perception of significant pain
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
Incidence of postoperative nausea and vomiting (PONV)
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
Side effects of lidocaine will be documented
Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
Time frame: 24 hours after surgery
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw