Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Acute Appendicitis

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03886896

Lido01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Group A - lidocaine group

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

Group B - control group

No Intervention group

Description:

Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion