Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting; Postoperative Pain; Acute Appendicitis
• Interventions: Drug: Lidocaine

• Registration Number: NCT03886896
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-21
• Study Start: 2019-03-22
• Study First Posted: 2019-03-22
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Age between 18 months and 18 year-old
2. Patients with American Society of Anaesthesiologists physical status (ASA) class 1/1E, 2/2E, 3/3E
3. Patients undergoing laparoscopic appendectomy

Exclusion Criteria

1. Allergy to local anesthetics or contraindication to use of lidocaine
2. Patients with American Society of Anaesthesiologists physical status (ASA) IV or more.
3. Severe cardiovascular disease
4. Preoperative bradycardia
5. Preoperative atrioventricular block
6. Renal failure
7. Chronic treatment with analgesics
8. Parents' refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - lidocaine group	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	24 hours after surgery	Total nalbuphine requirement in milligrams during the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Intraoperative opioid consumption	Intraoperative - from induction of anesthesia to extubation	Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Intraoperative volatile anesthetic consumption	Intraoperative - from induction of anesthesia to extubation	Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Incidence of postoperative nausea and vomiting (PONV)	24 hours after surgery	Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting \> 1/hr
Side effects of lidocaine will be documented	24 hours after surgery	Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
Time to first perception of significant pain	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.

Trial Locations

Locations (1)

University Clinic Centre of Medical University of Warsaw; 🇵🇱 Warsaw, Poland