Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.
Overview
- Phase
- Phase 4
- Intervention
- Lidocaine
- Conditions
- Acute Appendicitis
- Sponsor
- Medical University of Warsaw
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Postoperative opioid consumption
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Maciej Kaszyński
Principal Investigator
Medical University of Warsaw
Eligibility Criteria
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
Arms & Interventions
Group A - lidocaine group
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.
Intervention: Lidocaine
Outcomes
Primary Outcomes
Postoperative opioid consumption
Time Frame: 24 hours after surgery
Total nalbuphine requirement in milligrams during the first 24 hours after surgery
Secondary Outcomes
- Intraoperative opioid consumption(Intraoperative - from induction of anesthesia to extubation)
- Intraoperative volatile anesthetic consumption(Intraoperative - from induction of anesthesia to extubation)
- Incidence of postoperative nausea and vomiting (PONV)(24 hours after surgery)
- Side effects of lidocaine will be documented(24 hours after surgery)
- Time to first perception of significant pain(24 hours after surgery)