Inguinal HerniaNCT02007330
The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
A study testing Systemic intravenous lidocaine infusion and Normal saline infusion in people with Inguinal Hernia, run by Yonsei University at 1 site in South Korea.
Trial summary
Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Systemic intravenous lidocaine infusion and Normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chronic treatment with analgesics
- Previous history of laparoscopic operation
- Parents' refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 120-752
About this study
Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients
- Conditions
- Inguinal Hernia
- Being tested
- Systemic intravenous lidocaine infusion, Normal saline infusion
- Keywords
- systemic lidocaine, postoperative pain, recovery, pediatric, inguinal hernia, laparoscopy
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Normal saline infusionDrug
In group C, the patients receive same volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | Intravenous lidocaine infusion group Receives: Drug: Systemic intravenous lidocaine infusion |
| Group C | Placebo comparator | Intravenous normal saline infusion - control group Receives: Drug: Normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing postoperative pain
Assessing FLACC(Face-Legs-Activity-Crying-Consolability) score at 4, 8, 12 and 24hours after operation
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007330
- Sponsor's protocol ID
- 4-2013-0692
- Status last verified
- Jun 2015
- First submitted
- 5 Dec 2013
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
- ClinicalTrials.gov ID
- NCT02007330
- Acronym / sponsor ID
- 4-2013-0692
- Conditions
- Inguinal Hernia
- Keywords
- systemic lidocaine, postoperative pain, recovery, pediatric, inguinal hernia, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Drug: Systemic intravenous lidocaine infusionIntravenous lidocaine infusion group |
| Group C | Placebo comparator | Drug: Normal saline infusionIntravenous normal saline infusion - control group |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic intravenous lidocaine infusionIn 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. | Drug | Group L |
| Normal saline infusionIn group C, the patients receive same volume of normal saline | Drug | Group C |
Primary outcome
Assessing postoperative pain
Time frame: 24 hours after operation
Assessing FLACC(Face-Legs-Activity-Crying-Consolability) score at 4, 8, 12 and 24hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic intravenous lidocaine infusion and Normal saline infusion in people with Inguinal Hernia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing postoperative pain (time frame: 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.