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

33 Participants Needed

Trial Summary

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.

What data supports the idea that Bupivacaine Injection for Postoperative Pain is an effective drug?

The available research shows that Bupivacaine Injection, also known as Marcaine or Sensorcaine, is effective in reducing postoperative pain. In one study, patients who received Bupivacaine during breast reduction surgery reported less pain and needed fewer painkillers after the operation. Another study found that using Bupivacaine in surgical wounds helped reduce pain and the need for additional pain medication. Additionally, Bupivacaine was shown to be effective in reducing foot pain after surgery when applied directly to the wound. These studies suggest that Bupivacaine is a reliable option for managing pain after surgery. ^{1 2 3 4 5}

What safety data is available for Bupivacaine injections?

Bupivacaine, also known as Marcaine or Sensorcaine, has been studied for its safety in various contexts. In obstetrical analgesia, it is noted for minimal side effects on mothers and newborns when used in recommended doses. Intraoperative use in breast reduction surgery and postoperative pain relief in foot surgery has shown it to be effective with no significant side effects. A study on wound perfusion with bupivacaine reported no complications related to toxicity, hypersensitivity, infection, or impaired wound healing. Additionally, pooled safety data from 10 studies on liposome bupivacaine, a novel formulation, have been examined, indicating ongoing evaluation of its safety profile. ^{1 3 4 5 6}

Is the drug Bupivacaine Injection a promising treatment for postoperative pain?

Yes, Bupivacaine Injection is a promising treatment for postoperative pain. It provides excellent pain relief with minimal side effects, reduces the need for other pain medications, and is effective in various surgical procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone.

Research Team

Udit Chaddha, MBBS

Principal Investigator

Principal Investigator

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

2. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

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

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? [2018]

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

Postoperative pain relief using local anesthetic instillation. [2019]

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

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