Varied Lidocaine Injection Methods for Pain Management

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Lidocaine allergy, Bleeding disorders, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different methods of injecting lidocaine, a common numbing agent, affect pain during skin procedures. Researchers are examining how the speed and temperature of the injection might alter pain perception and whether adding a buffer (a substance to reduce acidity) to lidocaine makes a difference. People undergoing skin procedures who can clearly communicate and understand instructions are good candidates, especially if they have no lidocaine allergies or skin issues. As an unphased trial, this study allows participants to contribute to understanding and improving pain management techniques.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator.

What prior data suggests that these varied lidocaine injection methods are safe?

Research has shown that lidocaine, the treatment under study, has been used safely in many medical situations. According to FDA data, lidocaine is generally well-tolerated when used correctly. However, some people might experience higher levels of an enzyme called creatine phosphokinase, a normal reaction to muscle activity.

For the buffered version of lidocaine, studies have also found it safe and effective. Adding sodium bicarbonate (a buffering agent) to lidocaine can make the injection less painful by reducing its acidity. This method has been widely used without major safety concerns.

Overall, both regular and buffered lidocaine have demonstrated a good safety record in past research, supporting their use in medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores varied methods of administering lidocaine injections to enhance pain management. Unlike traditional lidocaine injections, which are typically given at a standard speed and temperature, this trial investigates the effects of injection speed (slow versus rapid) and temperature (room versus warm). Additionally, the trial examines the impact of buffering the lidocaine solution, which may reduce discomfort during injection. By comparing these variables, researchers hope to uncover the most effective and comfortable method for delivering lidocaine, potentially improving patient experiences and outcomes in pain management.

What evidence suggests that this trial's varied lidocaine injection methods could be effective for pain management?

Research has shown that lidocaine effectively numbs and reduces pain during medical procedures. In this trial, participants will receive lidocaine injections using different methods. Some will receive lidocaine that is warmed, either slowly or rapidly, which studies have found can make injections hurt less. Others will receive buffered or non-buffered lidocaine, as changing the pH balance, known as buffering, can also make injections less painful. Several studies found that buffered lidocaine is less painful than regular or even warmed lidocaine. These findings suggest that both warming and buffering lidocaine could help reduce pain during injections. ^{1 6 7 8 9}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-89 who are about to undergo dermatologic procedures and can understand and agree to the study's terms. It's not suitable for those who don't meet these age requirements or cannot give informed consent.

Inclusion Criteria

Subjects who are undergoing dermatologic procedures.

Subjects ages 18-89 year old.

The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive injections of lidocaine at varying rates and temperatures to assess pain perception

1 day

1 visit (in-person)

Treatment Part B

Participants receive injections of buffered or non-buffered lidocaine to assess pain perception

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-injection

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Buffer
• Lidocaine

Trial Overview The study tests how pain perception changes with different lidocaine injections during skin procedures. Part A examines the effect of injection speed and temperature, while Part B looks at whether adding a buffer to the anesthetic alters pain levels.

How Is the Trial Designed?

Group I: Slow, Warmed Experimental Treatment 3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group II: Slow, Room Temperature Experimental Treatment 3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group III: Rapid, Warmed Experimental Treatment 3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group IV: Rapid, Room Temperature Experimental Treatment 3 Interventions

In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.

Group V: Buffered Experimental Treatment 3 Interventions

In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Group VI: Non-Buffered Placebo Group 2 Interventions

In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Lidocaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

• Local anesthesia for minor surgical procedures
• Surface anesthesia for minor procedures
• Spinal anesthesia
• Epidural anesthesia

Approved in European Union as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Surface anesthesia

Approved in Canada as Lidocaine for:

• Local anesthesia
• Regional anesthesia

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3910524/

The effect of buffering on pain and duration of local ... A significant reduction in pain was apparent when lidocaine was buffered. A second outcome measured in the present study was the duration of anesthetic effect.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735675798901267

Pain reduction in lidocaine administration through buffering ... Buffered lidocaine was statistically less painful than both plain lidocaine and warmed lidocaine. Warmed, buffered lidocaine was significantly less painful than ...

3. journals.lww.com journals.lww.com/gastroenterologynursing/fulltext/2021/05000/effectiveness_of_buffered_lidocaine_for_local.3.aspx

Effectiveness of Buffered Lidocaine for Local Anesthesia... This simple intervention reduced patient's pain level by 1 point. Although this finding may not be considerable in itself, the project showed a sizeable ...

4. aafp.org aafp.org/pubs/afp/issues/2021/0115/od4.html

Buffering Lidocaine 1%/Epinephrine with Sodium ... Lido/Epi buffered with NaHCO 3 in a 3:1 ratio is significantly less painful during infiltration than unbuffered Lido/Epi and buffered Lido/Epi in a 9:1 ratio.

5. annemergmed.com annemergmed.com/article/S0196-0644(11)00573-7/fulltext

Does Buffered Lidocaine Decrease the Pain of Local ... Results of this meta-analysis strongly support the use of buffered lidocaine to reduce pain of infiltration in both parallel-group and crossover studies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9794676/

A Comparative Study to Evaluate the Anesthetic Efficacy of ... Background: The study aimed to compare the clinical efficacy, safety, and acceptability of buffered lidocaine (8.4% sodium bicarbonate and 2% ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02647892

Optimal Lidocaine Buffering to Reduce Injection Pain in ... Study Details | NCT02647892 | Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia | ClinicalTrials.gov.

8. tidsskriftet.no tidsskriftet.no/en/2017/05/klinisk-oversikt/reduced-pain-when-injecting-lidocaine

Reduced pain when injecting lidocaine Buffering lidocaine with sodium bicarbonate 0.5 mmol/ml at a ratio of 9 : 1 is the commonest method of reducing injection pain.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818002003690

Comparison of effects of lidocaine hydrochloride, buffered ... Main Results : Buffered lidocaine during intradermal infiltration was found to be significantly (p < 0.05) less painful than either lidocaine hydrochloride or ...