AzTrials
AzTrials

Fracture ArmPhase 4NCT07552766

A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements

A Phase 4 study testing Lidocaine Infusion in people with Fracture Arm and Fracture Closed of Lower End of Forearm, Unspecified, run by Nemours Children's Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Read more about this study

Who is it for?
Ages 3 to 18 years
What is being tested?
Lidocaine Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteUnited States
Study dates
24 Jun 2026to Jul 2029
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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients aged 3-18 years
  • Patients > 10 kg
  • Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius

Who cannot join

  • Children < 3 years or > 18 years
  • Patients with allergy to local anesthetics
  • Patients who are eligible for an receive a peripheral nerve block
  • Patients with multi-trauma or open fractures
  • Patients with previous history of seizure disorder
  • Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment
Show all 11Show fewer
  • Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)
  • Patients with chronic kidney or liver dysfunction
  • Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)
  • Patients with positive pregnancy test prior to surgery or nursing mothers
  • Patients who parents decline enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Snow, MD contact

302-824-1792

angela.snow@nemours.org

Isabela Santiago, BS contact

302-577-0126

isabela.santiago@nemours.org

United States1 site, 1 recruiting

  • Nemours Children's Hospital

    Wilmington, Delaware, 19803

    Isabela Santiago, 302-577-0126, isabela.santiago@nemours.org

    Angela Snow, MR

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double-blind Trial of the Impact of Intraoperative Intravenous Lidocaine Infusion on Total Opioid Requirements in Children Undergoing Surgical Fixation of Upper Extremity Long Bone Fractures Under General Anesthesia

This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery.

All participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes.

Patients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.

Being tested
Lidocaine Infusion, Standard of Care (SOC)
Medical subject headings
Elbow Fractures, Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine InfusionDrug

    Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.

  • Standard of Care (SOC)Other

    Standard of care

Study groups in NCT07552766
Study groupRoleWhat they receive
Patients receiving lidocaine infusionExperimentalNot described
Receives: Drug: Lidocaine Infusion
Patients receiving placeboPlacebo comparatorNot described
Receives: Other: Standard of Care (SOC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total perioperative opioid consumption

    Determine the effect of IVLI on intraoperative and postoperative opioid consumption in pediatric patients undergoing orthopedic surgery for long bone fractures of the upper extremity

    Measured: 60 minutes after patient arrival to post-anesthesia care unit (PACU)

Secondary outcomes (3)

  1. Postoperative pain scores

    The maximum postoperative pain scores in patients who received IVLI will be equivalent or less than patients who received placebo in PACU at 30, 60, and 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.

    Measured: 30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.

  2. Rescue Anti-Emetic Use

    Assess the effect of IVLI on rescue anti-emetic use and Phase 1 PACU length of stay.

    Measured: Duration of Phase 1 PACU length of stay

  3. Infusion and Surgical Length

    Evaluate if the infusion time of IVLI impacts post-operative opioid consumption and post- operative pain scores. Hypothesis: Patients who receive IVLI for > 2 hours will have lower post- operative opioid requirements and post-operative pain scores than patients who receive the infusion for < 2 hours.

    Measured: 60 minutes after patient arrives in post-anesthesia care unit (PACU)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start24 Jun 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552766
Sponsor's protocol ID
STUDY00000497
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Heath C, Hii J, Thalayasingam P, von Ungern-Sternberg BS, Sommerfield D. Perioperative intravenous lidocaine use in children. Paediatr Anaesth. 2023 May;33(5):336-346. doi: 10.1111/pan.14608. Epub 2022 Dec 4.

    PubMed 36424875

  • Pardessus P, Loiselle M, Brouns K, Horlin AL, Bruneau B, Maroun Y, Lagarde M, Deliere M, Julien-Marsollier F, Dahmani S. Intravenous lidocaine for postoperative analgesia management in paediatrics: A systematic review with meta-analysis of published studies. Eur J Anaesthesiol. 2024 Nov 1;41(11):856-864. doi: 10.1097/EJA.0000000000002046. Epub 2024 Jul 29.

    PubMed 39076006

  • Gupta A, Ashok V. Perioperative intravenous lignocaine for pediatric postoperative pain-A systematic review and meta-analysis. Paediatr Anaesth. 2025 Jan;35(1):25-32. doi: 10.1111/pan.15015. Epub 2024 Oct 4.

    PubMed 39365287

  • Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186/s12871-020-01218-0.

    PubMed 33397287

  • Hall EA, Sauer HE, Davis MS, Anghelescu DL. Lidocaine Infusions for Pain Management in Pediatrics. Paediatr Drugs. 2021 Jul;23(4):349-359. doi: 10.1007/s40272-021-00454-2. Epub 2021 May 26.

    PubMed 34036532

  • Chu R, Umukoro N, Greer T, Roberts J, Adekoya P, Odonkor CA, Hagedorn JM, Olatoye D, Urits I, Orhurhu MS, Umukoro P, Viswanath O, Hasoon J, Kaye AD, Orhurhu V. Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):216-259. doi: 10.64719/pb.4391.

    PubMed 33633427

  • Finholt DA, Stirt JA, DiFazio CA, Moscicki JC. Lidocaine pharmacokinetics in children during general anesthesia. Anesth Analg. 1986 Mar;65(3):279-82.

    PubMed 3954094

  • Mazoit JX, Dalens BJ. Pharmacokinetics of local anaesthetics in infants and children. Clin Pharmacokinet. 2004;43(1):17-32. doi: 10.2165/00003088-200443010-00002.

    PubMed 14715049

  • Foong KW, Loh PS, Chaw SH, Lo YL. Population Pharmacokinetics of IV Lidocaine and its Metabolites in Adult Surgical Patients. Pharm Res. 2025 Mar;42(3):451-473. doi: 10.1007/s11095-025-03835-1. Epub 2025 Feb 28.

    PubMed 40021547

  • Ochs HR, Knuchel M, Abernethy DR, Greenblatt DJ. Dose-independent pharmacokinetics of intravenous lidocaine in humans. J Clin Pharmacol. 1983 Apr;23(4):186-8. doi: 10.1002/j.1552-4604.1983.tb02723.x. No abstract available.

    PubMed 6863582

  • Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.

    PubMed 27199310

  • Keil LG, Sullivan MH, Dadoo S, Stillwagon MR, Vergun AD. How Much Opioid Do Kids Actually Need? A Prospective Study of Analgesic Prescribing and Postdischarge Opioid Use Among Pediatric Patients With Operative Fractures. J Pediatr Orthop. 2021 Nov-Dec 01;41(10):e871-e876. doi: 10.1097/BPO.0000000000001965.

    PubMed 34516466

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine Infusion in people with Fracture Arm and Fracture Closed of Lower End of Forearm, Unspecified, run by Nemours Children's Clinic at 1 site in United States.

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 11 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 6 Jul 2026. 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 United States. 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 Angela Snow, MD (302-824-1792, angela.snow@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total perioperative opioid consumption (time frame: 60 minutes after patient arrival to post-anesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07552766, which also lists 12 linked publications.

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 6 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in