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

Inguinal Hernia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007330
• Other study ID #: 4-2013-0692
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: June 5, 2015
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Systemic intravenous lidocaine infusion
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.
• Normal saline infusion
In group C, the patients receive same volume of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing postoperative pain	Assessing FLACC(Face-Legs-Activity-Crying-Consolability) score at 4, 8, 12 and 24hours after operation	24 hours after operation	No