NCT03886896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 22, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

March 15, 2019

Last Update Submit

May 18, 2020

Conditions

Acute AppendicitisPostoperative PainPostoperative Nausea and Vomiting

Keywords

systemic lidocainenalbuphinepostoperative painmultimodal analgesialaparoscopic appendectomylaparoscopyrecovery

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

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

    24 hours after surgery

Secondary Outcomes (5)

  • Intraoperative opioid consumption

    Intraoperative - from induction of anesthesia to extubation

  • Intraoperative volatile anesthetic consumption

    Intraoperative - from induction of anesthesia to extubation

  • Time to first perception of significant pain

    24 hours after surgery

  • Incidence of postoperative nausea and vomiting (PONV)

    24 hours after surgery

  • Side effects of lidocaine will be documented

    24 hours after surgery

Study Arms (2)

Group A - lidocaine group

EXPERIMENTAL

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

Group B - control group

NO INTERVENTION

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

Interventions

LidocaineDRUG

Lidocaine infusion during surgery

Also known as: Intravenous lidocaine infusion
Group A - lidocaine group

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Centre of Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (2)

  • 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.

    PMID: 35982198DERIVED

  • 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.

    PMID: 33397287DERIVED

MeSH Terms

Conditions

AppendicitisPain, PostoperativePostoperative Nausea and Vomiting

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Maciej Kaszyński

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 22, 2019

Study Start

March 22, 2019

Primary Completion

January 15, 2020

Study Completion

January 17, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

PL(1)