Bupivacaine Injection for Postoperative Pain
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.12345Why 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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo medical thoracoscopy with either ESP block with Bupivacaine or placebo
Post-operative Evaluation
Participants are evaluated post-operatively in the post-anesthesia care unit and 24 hours after the procedure
Follow-up
Participants are monitored for pain and recovery quality using various scales
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor