90 Participants NeededMy employer runs this trial

Lidocaine Infusion for Broken Arm

IS
AS
Overseen ByAngela Snow, MD
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a lidocaine infusion during surgery can reduce the need for pain medication in children with broken arms. Lidocaine, a medication often used to numb body areas, will be compared to a placebo (a treatment that looks the same but contains no active drug) to determine if it decreases the need for opioids, which are strong painkillers. Suitable candidates for this trial are children aged 3 to 18 undergoing surgery to repair a broken arm at Nemours Children's Hospital in the Delaware Valley. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on strong CYP450 inhibitors or have planned use of continuous infusion pain medications, you may not be eligible to participate.

What is the safety track record for lidocaine infusion?

Research has shown that intravenous lidocaine is generally safe and well-tolerated during surgeries. Studies comparing lidocaine to other pain relief methods, such as pethidine and morphine, have found that lidocaine maintains a good safety record. For example, one study found that lidocaine significantly reduced pain in patients with bone fractures without causing major side effects. Another study demonstrated that lidocaine also reduced the need for additional pain medication after surgery, aiding recovery.

Lidocaine infusions have been safely used in various procedures to ease pain and reduce the need for opioids (strong painkillers). This reduction is important because it means fewer side effects from opioids, such as nausea and drowsiness. While all medications can have side effects, serious reactions to lidocaine in these situations are rare.

Overall, evidence suggests that lidocaine is a safe option when properly monitored during surgery.12345

Why are researchers enthusiastic about this study treatment?

Lidocaine infusion is unique because it offers a potentially faster and more targeted approach to pain relief for a broken arm compared to traditional options like oral painkillers or topical analgesics. While most treatments focus on blocking pain at the site of injury or through the bloodstream, lidocaine infusion directly targets nerve signals responsible for pain. Researchers are excited about this treatment because it could provide rapid pain relief without the side effects commonly associated with systemic pain medications, offering a promising alternative for managing acute pain effectively.

What evidence suggests that lidocaine infusion might be an effective treatment for broken arm surgery?

Studies have shown that intravenous lidocaine can help manage pain from bone fractures. Research indicates it can lessen pain and reduce the need for extra pain medication after surgery. In this trial, some participants will receive a lidocaine infusion. Previous trials demonstrated that patients who received lidocaine reported less pain than those who did not. Another study found that lidocaine helped lower opioid use and improved recovery times. Overall, the evidence suggests that lidocaine is a promising option for reducing pain and aiding recovery in fracture surgeries.14567

Are You a Good Fit for This Trial?

This trial is for children ages 3 to 18 years, weighing over 10 kg, who are having surgery to fix a broken arm or forearm at Nemours Children's Hospital - Delaware Valley.

Inclusion Criteria

I am between 3 and 18 years old.
I weigh more than 10 kilograms.
I am having surgery at Nemours for a fracture in my arm between the elbow and wrist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative intravenous lidocaine infusion or placebo during surgery

Intraoperative period
1 visit (in-person)

Postoperative Monitoring

Opioid consumption and pain scores are measured intraoperatively and throughout the postoperative recovery

60 minutes after arrival to PACU
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid use

PACU stay duration

What Are the Treatments Tested in This Trial?

Interventions

  • Lidocaine Infusion

Trial Overview

The study compares giving IV lidocaine during surgery versus a placebo (saline) in kids having arm fracture repairs. All patients get standard anesthesia and pain care. The main goal is to see if lidocaine reduces the need for opioids after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Patients receiving lidocaine infusionExperimental Treatment1 Intervention
Group II: Patients receiving placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials
128
Recruited
18,000+

Citations

Comparing intravenous lidocaine and pethidine for pain ...

The administration of intravenous lidocaine is beneficial for managing pain in femoral bone fractures, suggesting that lidocaine could be a potent alternative ...

Lidocaine Infusion for Broken Arm · Info for Participants

... Lidocaine Infusion will have tolerable side effects & efficacy for patients with Broken Arm, Forearm Fractures, Internal Fracture Fixation ...

A Clinical Trial on the Use of Lidocaine Infusion During ...

Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the ...

Efficacy and safety of perioperative intravenous lidocaine ...

Our meta-analysis of 14 RCTs revealed that perioperative lidocaine infusions reduced the incidence of CPSP at 3 and 6 months post-surgery. In ...

Comparison of the Effects of Lidocaine Versus Magnesium ...

In this study, lidocaine infusion had a better analgesic effect 30 min postoperatively and reduced the total rescue analgesic requirements. This result is ...

How Lidocaine Affects Outcomes In Orthopedic Surgery ...

This study will evaluate the effect of intraoperative lidocaine infusion on postoperative orientation and concentration in elderly patients ...

Intravenous Lidocaine for Postoperative Analgesia in 90 ...

The present study was designed to test the primary hypothesis that intravenous lidocaine reduces postoperative pain, measured at rest and during movement, using ...