Bupivacaine for Pain Management

Overseen By NYUSOM IRB

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: New York University

Must not be taking: Opioids, Marijuana

Disqualifiers: Pregnancy, High blood pressure, Tobacco, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how an extra shot of a long-lasting anesthetic, bupivacaine, can improve pain management and quality of life after a root canal. The study compares three groups: one receiving the extra anesthetic, one receiving a placebo injection, and one receiving no extra shot, to assess their effects on pain levels and medication use. It suits individuals scheduled for a root canal due to symptomatic irreversible pulpitis (a painful tooth condition) who do not use tobacco or drugs. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken opioids for pain control.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that bupivacaine is generally well-tolerated for managing pain after surgeries or dental work. As a local anesthetic, it numbs specific areas to help reduce pain.

However, high doses can lead to side effects, including heart problems, so careful monitoring of dosage is crucial. Bupivacaine has been safely used in skin-related procedures, indicating it can be a reliable option when used correctly.

In this trial, bupivacaine is administered as an additional step after a dental procedure to evaluate its effectiveness in managing pain without causing unwanted effects. Prospective participants should discuss any concerns with the study team to determine if participation is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using supplemental postoperative bupivacaine for pain management because it offers a unique approach compared to standard options like NSAIDs or opioids. This treatment involves an additional injection of bupivacaine, a long-acting local anesthetic, which can extend pain relief without the systemic side effects commonly associated with oral pain medications. By delivering targeted pain relief directly at the site of surgery, this method minimizes overall drug exposure and potential adverse effects, providing a potentially safer and more effective way to manage postoperative pain.

What evidence suggests that supplemental postoperative bupivacaine could be effective for pain management?

Studies have shown that bupivacaine is a local anesthetic used to manage pain after surgeries. Research indicates that the standard form of bupivacaine doesn't always outperform a simple saltwater solution (normal saline) in reducing pain after some surgeries. However, some studies suggest that a long-lasting version of bupivacaine can be more effective in certain situations. In this trial, participants in the "Supplemental Postoperative Bupivacaine" arm will receive the regular form of bupivacaine, which might not be as effective as the long-lasting version. Therefore, while it is used for pain management, its success can vary depending on the situation and the type of bupivacaine used. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone nonsurgical endodontic treatment (root canal). Participants should be in good health overall and not currently using any pain medication that could interfere with the study. There are no specific inclusion or exclusion criteria provided.

Inclusion Criteria

I am in good or stable health with only mild systemic disease.

Patients with a blood pressure below 160/100

Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English

Exclusion Criteria

Patients who are unable to consent and do not understand or are unable to read the questionnaires

Pregnant patients

Patients with a blood pressure of 160/100 or greater

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo non-surgical endodontic treatment followed by either a supplemental bupivacaine injection, a mock injection, or no additional injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for quality of life, pain levels, and analgesic use for four days following treatment

4 days

Daily monitoring (virtual or self-reported)

What Are the Treatments Tested in This Trial?

Interventions

• Supplemental Postoperative Bupivacaine

Trial Overview

The study is testing whether a supplemental injection of Bupivacaine, a long-acting anesthetic, after root canal treatment can reduce pain and improve quality of life compared to a placebo injection or no additional anesthetic at all.

How Is the Trial Designed?

Group I: Supplemental Postoperative Bupivacaine Experimental Treatment 1 Intervention

An additional injection, 1 carpule (1.8 mL) of 0.5% bupivacaine with 1:200,000 epinephrine, will be given to patients in this treatment arm, after their standard endodontic procedure is complete.

Group II: No Additional Injection Active Control 1 Intervention

After standard endodontic procedure, no additional injection will be given.

Group III: Mock/Placebo Injection Placebo Group 1 Intervention

If assigned to this arm, the patient will be shown the removal of a needle cap for an anesthetic syringe. The tip will be bent and placed in the patient's mouth, but no tissue penetration will occur. No solution of anesthetic will be delivered.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

Liposomal bupivacaine (Exparel) has been shown to be a safe and effective option for managing postoperative pain in plastic surgery, based on a review of eight studies involving 405 patients.

Compared to traditional pain management methods, liposomal bupivacaine was found to be equivalent or more effective, suggesting it could serve as a less invasive alternative to more complex pain management systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Vyas, KS., Rajendran, S., Morrison, SD., et al.[2022]

A review of 90 trials (31 for pregabalin and 59 for gabapentin) showed that only 24% adequately reported adverse events (AEs) at specified perioperative time points, highlighting a significant gap in safety assessment in post-operative pain treatment studies.

Only 7 out of 10 recommendations from the CONSORT Extension for Harms were typically followed, with 18% of trials not describing their AE assessment methods, indicating a need for improved reporting standards to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. Hoffer, D., Smith, SM., Parlow, J., et al.[2018]

Multimodal analgesia that minimizes opioid use after surgery can reduce postoperative pain and the risk of complications, highlighting the importance of using non-opioid analgesics like NSAIDs, gabapentinoids, and regional anesthesia techniques.

Non-opioid analgesics generally have a low risk of adverse events when used appropriately, although certain medications like α-2 agonists and gabapentinoids may have specific risks, emphasizing the need for standardized protocols to enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. Jin, Z., Lee, C., Zhang, K., et al.[2021]

A study of 150 adult patients using epidural catheters for postoperative pain management showed that 87.8% rated their pain service as very good or good, indicating high satisfaction with the treatment.

Despite the high satisfaction rates, common side effects included bladder dysfunction (19%) and intermittent motor blockade (18%), particularly with lumbar catheters, highlighting the need for ongoing improvements in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does patient satisfaction correlate with pain level during patient-monitored epidural analgesia. Evaluation of data from postoperative pain service]. Gottschalk, A., Freitag, M., Liehr, K., et al.[2018]

In a study involving 823 patients across various surgical settings, liposome bupivacaine demonstrated a lower incidence of adverse events (62%) compared to bupivacaine HCl (75%) and placebo (43%), indicating better tolerability.

Serious adverse events were less common in the liposome bupivacaine group (2.7%) compared to bupivacaine HCl (5.4%), suggesting that liposome bupivacaine may be a safer option for local analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. Viscusi, ER., Sinatra, R., Onel, E., et al.[2022]

Liposome bupivacaine is a promising alternative for post-surgical pain management, potentially reducing the need for opioids and their associated adverse effects, based on clinical trial data and safety reviews.

This liposomal formulation allows for a single administration directly at the surgical site, which may enhance pain control while minimizing risks linked to traditional opioid analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine 2 years post-launch: a look back and a look forward. Viscusi, ER.[2022]

A study involving 453 patients who underwent liver resection found that administering celecoxib for postoperative pain management did not increase the risk of major complications compared to those who did not receive the medication.

Celecoxib was shown to be safe for use after liver surgery, with similar rates of overall complications, gastrointestinal bleeding, acute renal failure, and portal vein thrombosis between the celecoxib and non-celecoxib groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Administration of Celecoxib as an Analgesic after Liver Resection Is Safe. Hokuto, D., Nomi, T., Kawaguchi, C., et al.[2017]

HYR-PB21-LA, a new microparticle suspension of bupivacaine pamoate, demonstrated significantly longer-lasting local anesthesia effects compared to traditional bupivacaine hydrochloride, lasting up to five times longer in animal tests.

In head-to-head comparisons, HYR-PB21-LA showed superior efficacy over liposomal bupivacaine, providing effective pain relief for up to 8 hours versus just 1 hour with the liposomal formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HYR-PB21-LA, a potential extended-release bupivacaine formulation, produces long-lasting local anesthesia in rats and guinea pigs. Peng, J., Liu, C., Liu, J., et al.[2021]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0278239121007552

A Triple-Blind Randomized Controlled Clinical Trial

Postoperative use of bupivacaine did not show a superior analgesic efficacy when compared with normal saline in controlling acute postoperative pain after BSSO.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7967071/

Effectiveness of Standard Local Anesthetic Bupivacaine and ...

This randomized clinical trial investigates the effectiveness of liposomal bupivacaine vs standard bupivacaine for postoperative pain in patients with truncal ...

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2777506

Standard vs Liposomal Bupivacaine for Postoperative Pain ...

Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...

4.

nature.com

nature.com/articles/s41598-025-10616-8

Intrapleural injection of bupivacaine liposome for pain ...

The objective of this study was to investigate the impact of bupivacaine liposomes on postoperative pain management in patients undergoing thoracoscopic lung ...

5.

ajog.org

ajog.org/article/S0002-9378(18)30821-4/abstract

Liposomal bupivacaine efficacy for postoperative pain ...

Previous studies have reported the beneficial use of a single intraoperative injection of extended-release liposomal bupivacaine in postoperative pain ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2018/018304s049lbl.pdf

November 2018 Sensorcaine® (bupivacaine HCl Injection ...

There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). Information ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/bupivacaine-injection-route/description/drg-20406723

Bupivacaine (injection route) - Side effects & uses

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work.

8.

reference.medscape.com

reference.medscape.com/drug/marcaine-sensorcaine-bupivacaine-343360

Marcaine, Sensorcaine (bupivacaine) dosing, indications, ...

Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on ...

9.

cdn.pfizer.com

cdn.pfizer.com/pfizercom/products/material_safety_data/Bupivacaine_HCl__inj_09-Oct-2018_0.pdf

SAFETY DATA SHEET

HYDROCHLORIC ACID. Material Name: Bupivacaine Hydrochloride Injection (Hospira,. Inc.) Bacterial Mutagenicity (Ames). Salmonella. Negative.

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04362566?tab=table

NCT04362566 | Bupivacaine for Post-operative Pain in Mohs

It is generally well tolerated, carrying a class-effect risk of cardiac toxicity in high doses as does lidocaine, but has been shown to be safe in dermatologic ...