- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007330
The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
June 5, 2015 updated by: Yonsei University
Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group L
Intravenous lidocaine infusion group
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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.
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Placebo Comparator: Group C
Intravenous normal saline infusion - control group
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In group C, the patients receive same volume of normal saline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing postoperative pain
Time Frame: 24 hours after operation
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Assessing FLACC(Face-Legs-Activity-Crying-Consolability) score at 4, 8, 12 and 24hours after operation
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24 hours after operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
December 5, 2013
First Submitted That Met QC Criteria
December 5, 2013
First Posted (Estimate)
December 10, 2013
Study Record Updates
Last Update Posted (Estimate)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 5, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Hernia, Abdominal
- Hernia
- Hernia, Inguinal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 4-2013-0692
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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