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The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Systemic intravenous lidocaine infusion
Normal saline infusion
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inguinal Hernia focused on measuring systemic lidocaine, postoperative pain, recovery, pediatric, inguinal hernia, laparoscopy

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 1 and 6 year-old
  • ASA class 1 and 2
  • Pediatric Inguinal hernia patients who are scheduled for elective laparoscopic inguinal hernia repair

Exclusion Criteria:

  • Allergy to local anesthetics or contraindication to use of lidocaine
  • Current active upper respiratory infection or history of upper respiratory infection within 2 weeks
  • Severe cardiovascular disease
  • Renal failure
  • Liver failure
  • Neurologic and psychologic disease
  • Chronic treatment with analgesics
  • Previous history of laparoscopic operation
  • Parents' refusal

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group L

Group C

Arm Description

Intravenous lidocaine infusion group

Intravenous normal saline infusion - control group

Outcomes

Primary Outcome Measures

Assessing postoperative pain
Assessing FLACC(Face-Legs-Activity-Crying-Consolability) score at 4, 8, 12 and 24hours after operation

Secondary Outcome Measures

Full Information

First Posted
December 5, 2013
Last Updated
June 5, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02007330
Brief Title
The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
systemic lidocaine, postoperative pain, recovery, pediatric, inguinal hernia, laparoscopy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Experimental
Arm Description
Intravenous lidocaine infusion group
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Intravenous normal saline infusion - control group
Intervention Type
Drug
Intervention Name(s)
Systemic intravenous lidocaine infusion
Intervention Description
In group L, intravenous lidocaine infusion (0.1mg/kg) for 1minutes after induction of anesthesia. After 1 minutes, lidocaine infusion continued at rate of 1.5mg/kg/hr during operation, and discontinued before move the patients to PACU.
Intervention Type
Drug
Intervention Name(s)
Normal saline infusion
Intervention Description
In group C, the patients receive same volume of normal saline
Primary Outcome Measure Information:
Title
Assessing postoperative pain
Description
Assessing FLACC(Face-Legs-Activity-Crying-Consolability) score at 4, 8, 12 and 24hours after operation
Time Frame
24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 1 and 6 year-old ASA class 1 and 2 Pediatric Inguinal hernia patients who are scheduled for elective laparoscopic inguinal hernia repair Exclusion Criteria: Allergy to local anesthetics or contraindication to use of lidocaine Current active upper respiratory infection or history of upper respiratory infection within 2 weeks Severe cardiovascular disease Renal failure Liver failure Neurologic and psychologic disease Chronic treatment with analgesics Previous history of laparoscopic operation Parents' refusal
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children

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