NCT02007330

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

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

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

December 5, 2013

Last Update Submit

June 5, 2015

Conditions

Inguinal Hernia

Keywords

systemic lidocainepostoperative painrecovery, pediatricinguinal hernialaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Assessing postoperative pain

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

    24 hours after operation

Study Arms (2)

Group L

EXPERIMENTAL

Intravenous lidocaine infusion group

Drug: Systemic intravenous lidocaine infusion

Group C

PLACEBO COMPARATOR

Intravenous normal saline infusion - control group

Drug: Normal saline infusion

Interventions

Systemic intravenous lidocaine infusionDRUG

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.

Group L
Normal saline infusionDRUG

In group C, the patients receive same volume of normal saline

Group C

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hernia, InguinalPain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

KR(1)