Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886896
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Maciej Kaszyński, 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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Postoperative Pain Postoperative Nausea and Vomiting Drug: Lidocaine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Lidocaine
Lidocaine infusion during surgery
Other Name: Intravenous lidocaine infusion

No Intervention: Group B - control group
Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion



Primary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: 24 hours after surgery ]
    Total nalbuphine requirement in milligrams during the first 24 hours after surgery


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886896


Locations
Layout table for location information
Poland
University Clinic Centre of Medical University of Warsaw
Warsaw, Poland, 02-091
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Layout table for investigator information
Principal Investigator: Maciej Kaszyński Medical University of Warsaw
Layout table for additonal information
Responsible Party: Maciej Kaszyński, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03886896    
Other Study ID Numbers: Lido01
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maciej Kaszyński, Medical University of Warsaw:
systemic lidocaine
nalbuphine
postoperative pain
multimodal analgesia
laparoscopic appendectomy
laparoscopy
recovery
Additional relevant MeSH terms:
Layout table for MeSH terms
Appendicitis
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Nausea
Signs and Symptoms, Digestive
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action