Bupivacaine Injection for Postoperative Pain

Overseen By Udit Chaddha, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Allergy to Bupivacaine, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Bupivacaine, a local anesthetic, to determine if it can reduce pain after medical thoracoscopy, a type of chest examination. It compares pain levels between participants receiving a special injection (erector spinae plane block) with Bupivacaine and those receiving a placebo, a harmless substance with no effect. Individuals referred for a medical thoracoscopy without allergies to Bupivacaine or similar medications may qualify for the trial. The goal is to determine if the Bupivacaine injection provides better pain relief than usual care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in pain management.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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

Research has shown that bupivacaine is generally safe for people and can reduce pain after surgery, particularly if the procedure lasts more than 40 minutes. Some patients experience less pain and require fewer painkillers when bupivacaine is administered.

Traditional bupivacaine relieves pain for about 8 hours, but newer versions, such as liposomal bupivacaine, can last up to 3 days. This extended duration may provide longer-lasting pain relief after surgery. Studies have not identified any major safety issues, indicating that bupivacaine is safe for managing post-surgical pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the bupivacaine injection for postoperative pain because it targets the nerve pathways more precisely and directly than standard systemic pain medications like opioids. This treatment involves an erector spinae plane block, where bupivacaine is injected near the spine to block pain signals, potentially leading to more effective pain relief and fewer side effects. Unlike traditional methods, which often involve oral or intravenous opioids with widespread effects, bupivacaine offers localized pain control, reducing the risk of systemic side effects and the potential for dependency. This approach not only aims for better pain management but also enhances recovery by minimizing opioid-related complications.

What evidence suggests that this trial's treatments could be effective for reducing pain after medical thoracoscopy?

Research shows that bupivacaine reduces pain after surgery. In this trial, participants in the "ESP with Bupivacaine Group" will receive an erector spinae plane block with bupivacaine. Studies have found that bupivacaine improves pain relief and lowers the need for pain medications. For example, patients who received bupivacaine experienced less pain and required fewer opioids for management. In some cases, using bupivacaine also led to shorter hospital stays, suggesting quicker recovery. Overall, evidence supports bupivacaine's effectiveness in managing post-surgical pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Udit Chaddha, MBBS

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for individuals undergoing medical thoracoscopy, a procedure to look inside the chest. Participants should be those who need this procedure and are interested in managing postoperative pain. Specific eligibility details aren't provided, but typically participants must meet certain health criteria.

Inclusion Criteria

I have been referred for a medical thoracoscopy.

Exclusion Criteria

Allergic reaction to Bupivacaine

Allergies to lidocaine or other local anesthetics

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo medical thoracoscopy with either ESP block with Bupivacaine or placebo

1 day

1 visit (in-person)

Post-operative Evaluation

Participants are evaluated post-operatively in the post-anesthesia care unit and 24 hours after the procedure

24 hours

2 visits (in-person)

Follow-up

Participants are monitored for pain and recovery quality using various scales

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview

The study tests if injecting Bupivacaine near the spine (Erector Spinae Plane Block) reduces pain after chest examinations compared to no injection (placebo). It's a triple-blind study, meaning neither patients, doctors nor assessors know who gets the real treatment or placebo.

How Is the Trial Designed?

Group I: ESP with Bupivacaine Group Experimental Treatment 2 Interventions

Erector spinae plane block with bupivacaine.

Group II: ESP with Placebo Placebo Group 2 Interventions

Erector spinae plane injection with a placebo (normal saline).

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

Wound perfusion with bupivacaine provides effective and sustained postoperative pain relief without any complications or side effects, indicating its safety for use in patients.

Both intermittent and continuous wound perfusion significantly reduced postoperative pain and analgesic requirements, suggesting that this technique can enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? Thomas, DF., Lambert, WG., Williams, KL.[2018]

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7002882/

Effect of bupivacaine on postoperative pain and analgesics ...

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The utilization of liposomal bupivacaine was associated with improved pain outcomes, decreased opioid consumption, and shortened length of stay.

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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 ...

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Postoperative Analgesic Effectiveness of Bupivacaine With ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2949962325000105

Comparing intraoperative administration of long-acting ...

This study compared postoperative pain outcomes with LB versus MCs such as ropivacaine-epinephrine-clonidine-ketorolac, bupivacaine-epinephrine-dexamethasone, ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33724391/

Effectiveness of Standard Local Anesthetic Bupivacaine and ...

Importance: Liposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352587825001160

Research progress of liposomal bupivacaine and its value ...

They observed that patients in the LB group reported significantly lower pain scores at both 24 and 48 h post-surgery compared to those who received ...

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nature.com

nature.com/articles/s41598-025-17790-9

Preclinical safety and feasibility of a bupivacaine-loaded ...

Severe postoperative pain typically lasts for 3 days after spine surgery, and can significantly influence surgical outcomes and patient ...