Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
Primary Purpose
Acute Appendicitis, Postoperative Pain, Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Appendicitis focused on measuring systemic lidocaine, nalbuphine, postoperative pain, multimodal analgesia, laparoscopic appendectomy, laparoscopy, recovery
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
Sites / Locations
- University Clinic Centre of Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A - lidocaine group
Group B - control group
Arm 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.
Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion
Outcomes
Primary Outcome Measures
Postoperative opioid consumption
Total nalbuphine requirement in milligrams during the first 24 hours after surgery
Secondary Outcome Measures
Intraoperative opioid consumption
Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Intraoperative volatile anesthetic consumption
Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Time to first perception of significant pain
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.
Incidence of postoperative nausea and vomiting (PONV)
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
Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
Full Information
NCT ID
NCT03886896
First Posted
March 15, 2019
Last Updated
May 18, 2020
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT03886896
Brief Title
Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
Official Title
Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis, Postoperative Pain, Postoperative Nausea and Vomiting
Keywords
systemic lidocaine, nalbuphine, postoperative pain, multimodal analgesia, laparoscopic appendectomy, laparoscopy, recovery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A - lidocaine group
Arm Type
Experimental
Arm 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.
Arm Title
Group B - control group
Arm Type
No Intervention
Arm Description
Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Intravenous lidocaine infusion
Intervention Description
Lidocaine infusion during surgery
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Total nalbuphine requirement in milligrams during the first 24 hours after surgery
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Intraoperative opioid consumption
Description
Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Time Frame
Intraoperative - from induction of anesthesia to extubation
Title
Intraoperative volatile anesthetic consumption
Description
Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Time Frame
Intraoperative - from induction of anesthesia to extubation
Title
Time to first perception of significant pain
Description
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.
Time Frame
24 hours after surgery
Title
Incidence of postoperative nausea and vomiting (PONV)
Description
Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting > 1/hr
Time Frame
24 hours after surgery
Title
Side effects of lidocaine will be documented
Description
Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Kaszyński
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Centre of Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35982198
Citation
Kaszynski M, Stankiewicz B, Palko KJ, Darowski M, Pagowska-Klimek I. Impact of lidocaine on hemodynamic and respiratory parameters during laparoscopic appendectomy in children. Sci Rep. 2022 Aug 18;12(1):14038. doi: 10.1038/s41598-022-18243-3.
Results Reference
derived
PubMed Identifier
33397287
Citation
Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186/s12871-020-01218-0.
Results Reference
derived
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Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
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