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

Trial Summary

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.

What data supports the effectiveness of the drug bupivacaine for pain management?

Research shows that bupivacaine, when used continuously after surgeries, can effectively provide pain relief and reduce the need for other pain medications, helping patients recover faster. ^{1 2 3 4 5}

Is bupivacaine safe for pain management in humans?

Liposome bupivacaine, a form of bupivacaine, has been studied in several clinical trials and is considered a safe option for managing post-surgical pain, potentially reducing the need for opioids, which have more side effects. ^{6 7 8 9 10}

How does bupivacaine differ from other pain management drugs?

Bupivacaine is unique because it can be formulated as a slow-release or liposomal version, which allows for a longer-lasting effect compared to traditional forms. This means it can provide extended pain relief after surgery, reducing the need for additional pain medications. ^{11 12 13 14 15}

What is the purpose of this trial?

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of Epidural Bupivacaine and Buprenorphine to Bupivacaine and Butorphanol for Postoperative Analgesia in Lower Limb Orthopedic Surgery. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Does patient satisfaction correlate with pain level during patient-monitored epidural analgesia. Evaluation of data from postoperative pain service]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of continuous wound infusion of local anesthetics after abdominal surgeries. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Combination of pre-emptive port-site and intraoperative intraperitoneal ropivacaine for reduction of postoperative pain: a prospective cohort study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Continuous spinal analgesia or opioid-added continuous epidural analgesia for postoperative pain control after hip replacement. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Administration of Celecoxib as an Analgesic after Liver Resection Is Safe. [2017]

11. Germany pubmed.ncbi.nlm.nih.gov

Postoperative pain after bupivacaine supplementation in mandibular third molar surgery: splint-mouth randomized double blind controlled clinical trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Mitigation of experimental, chronic post-thoracotomy pain by preoperative infiltration of local slow-release bupivacaine microspheres. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. [2022]

15. England pubmed.ncbi.nlm.nih.gov

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