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Completed

NCT Number: NCT03886896

Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Lidocaine infusion during surgery

Other names: Intravenous lidocaine infusion

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 hours after surgery

    Total nalbuphine requirement in milligrams during the first 24 hours after surgery

Secondary outcomes

  1. Intraoperative opioid consumption

    Time frame: Intraoperative - from induction of anesthesia to extubation

    Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight

  2. Intraoperative volatile anesthetic consumption

    Time frame: Intraoperative - from induction of anesthesia to extubation

    Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.

  3. Time to first perception of significant pain

    Time frame: 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.

  4. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: 24 hours after surgery

    Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting > 1/hr

  5. Side effects of lidocaine will be documented

    Time frame: 24 hours after surgery

    Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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