Pain Management After SurgeryPhase 4NCT06710405
The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery
A Phase 4 study testing Lidocaine (drug) in people with Pain Management After Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Pain Management After Surgery
- What is being tested?
- Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Dec 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection
Who cannot join
- cardiac dysfunction requiring vasopressors or inotropic agents
- atrioventricular block or bradycardia
- Liver or kidney dysfunction
- Hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Ji-Hyun Lee, MD, PhD, +82-10-7665-8848, muslab6@snu.ac.kr
About this study
Official title: The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery:Prospective, Randomized Controlled Trial
This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.
- Conditions
- Pain Management After Surgery
- Being tested
- Lidocaine (drug), Saline infusion (placebo)
- Keywords
- pediatric, thoracoscopic surgery, pain control, lidocaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Drug
a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr.
Saline infusion (placebo)Drug
Continuous infusion of normal saline in the same volume as that administered to the lidocaine group.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | Anesthesia induction is performed according to the standard protocol. Monitoring includes electrocardiography, pulse oximetry, arterial blood pressure, depth of anesthesia (Patient State Index, PSI), and pain score (Analgesia Nociception Index).
In the lidocaine group, a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr. Receives: Drug: Lidocaine (drug) |
| Control group | Placebo comparator | The control group receives a continuous infusion of normal saline in the same volume as that administered to the lidocaine group. Receives: Drug: Saline infusion (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC (ace, Legs, Activity, Cry, Consolability scale) Score
Highest FLACC Score recorded in the postanesthesia care unit (The scale is scored in a range of 0-10 with 0 representing no pain.)
Measured: up to 1 hour after surgery
Secondary outcomes (5)
Remifentanil dose
Total amount of remifentanil administered during surgery
Measured: throughout surgery (up to 3 hours)
ANI (Analgesia Nociception Index)
ANI (Analgesia Nociception Index) values during surgery (scale ranging from 0 (indicating maximum pain) to 100 (indicating no pain))
Measured: throughout surgery (up to 3 hours)
FLACC scores
FLACC scores at 6 hours, 12 hours, and 24 hours postoperatively
Measured: 6 hours, 12 hours, and 24 hours postoperatively
Total analgesic dosage administered postoperatively
Measured: up to 3 days after surgery
Postoperative complications
Measured: until discharge (up to 3-4 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start9 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management After SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710405
- Sponsor's protocol ID
- H2409-100-1573
- Status last verified
- May 2025
- First submitted
- 25 Nov 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery:Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06710405
- Acronym / sponsor ID
- H2409-100-1573
- Conditions
- Pain Management After Surgery
- Keywords
- pediatric, thoracoscopic surgery, pain control, lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- 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.
This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: Lidocaine (drug)Anesthesia induction is performed according to the standard protocol. Monitoring includes electrocardiography, pulse oximetry, arterial blood pressure, depth of anesthesia (Patient State Index, PSI), and pain score (Analgesia Nociception Index). In the lidocaine group, a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr. |
| Control group | Placebo comparator | Drug: Saline infusion (placebo)The control group receives a continuous infusion of normal saline in the same volume as that administered to the lidocaine group. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection
Key exclusion criteria (4 listed)
- cardiac dysfunction requiring vasopressors or inotropic agents
- atrioventricular block or bradycardia
- Liver or kidney dysfunction
- Hypersensitivity to local anesthetics
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 |
|---|---|---|
| Lidocaine (drug)a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr. | Drug | Lidocaine group |
| Saline infusion (placebo)Continuous infusion of normal saline in the same volume as that administered to the lidocaine group. | Drug | Control group |
Primary outcome
FLACC (ace, Legs, Activity, Cry, Consolability scale) Score
Time frame: up to 1 hour after surgery
Highest FLACC Score recorded in the postanesthesia care unit (The scale is scored in a range of 0-10 with 0 representing no pain.)
5 secondary outcomes
Remifentanil dose
Time frame: throughout surgery (up to 3 hours)
ANI (Analgesia Nociception Index)
Time frame: throughout surgery (up to 3 hours)
FLACC scores
Time frame: 6 hours, 12 hours, and 24 hours postoperatively
Total analgesic dosage administered postoperatively
Time frame: up to 3 days after surgery
Postoperative complications
Time frame: until discharge (up to 3-4 days after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine (drug) in people with Pain Management After Surgery, run by Seoul National University Hospital 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hyun Lee, MD, PhD (82-2-2072-3661, muslab6@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC (ace, Legs, Activity, Cry, Consolability scale) Score (time frame: up to 1 hour after surgery). 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 14 May 2025.