Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.

Conditions
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Acute Appendicitis, Postoperative Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 months and 18 year-old Patients with American Society of Anaesthesiologists physical status (ASA) class 1/1E, 2/2E, 3/3E Patients undergoing laparoscopic appendectomy Exclusion Criteria: Allergy to local anesthetics or contraindication to use of lidocaine Patients with American Society of Anaesthesiologists physical status (ASA) IV or more. Severe cardiovascular disease Preoperative bradycardia Preoperative atrioventricular block Renal failure Chronic treatment with analgesics Parents' refusal

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - lidocaine group<br>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<br>* Lidocaine infusion during surgery<br>* Other names: Intravenous lidocaine infusion;|
| No Intervention: Group B - control group<br>Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | Total nalbuphine requirement in milligrams during the first 24 hours after surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative opioid consumption | Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight | 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. | 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. | 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 | 24 hours after surgery | 
| Side effects of lidocaine will be documented | Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia. | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic lidocaine, nalbuphine, postoperative pain, multimodal analgesia, laparoscopic appendectomy, laparoscopy, recovery