Bupivacaine for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether bupivacaine, a strong pain medication, can reduce pain after nose surgery (septorhinoplasty). Researchers will compare the effects of bupivacaine to a saline solution to determine which better manages pain. Individuals undergoing their first nose surgery at specific military hospitals, without issues like alcohol abuse or opiate use disorder, may be suitable candidates. The goal is to identify the best method for managing post-surgery pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking pain management solution.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it excludes those with a history of mental health medication use or opiate use disorder.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, researchers focused on the safety of Exparel, a type of bupivacaine, examining side effects such as nausea, itching, and heart or lung issues. These side effects occurred but were not very common. Another study showed that patients using Exparel experienced less pain after surgery compared to those who did not use it, suggesting it is generally well-tolerated. Other studies have considered Exparel safe for people.
Since this trial uses Exparel, which is in a later stage of research, earlier stages have already assessed its safety. This provides some confidence in the treatment's safety for people. However, like any treatment, there can still be risks of side effects, even if they are usually mild or uncommon.12345Why do researchers think this study treatment might be promising?
Exparel is unique because it delivers bupivacaine in a long-acting form for postoperative pain relief. Unlike standard treatments, which often require multiple doses of local anesthetics or systemic painkillers, Exparel is designed to be administered as a single dose, providing extended pain control. This extended-release formula targets the surgical site directly, potentially reducing the need for additional medications and minimizing side effects associated with systemic pain management. Researchers are excited about its promise to improve patient comfort and streamline postoperative care.
What evidence suggests that Bupivacaine is effective for postoperative pain?
In this trial, participants will receive either Exparel, a type of pain medication, or a placebo comparator. Studies have shown that Exparel effectively reduces pain after surgery. Specifically, research indicates it significantly lessens pain in the first 24 to 36 hours compared to a placebo, allowing patients to feel less pain soon after surgery. However, some studies found no major differences in pain relief when compared to other pain medications. Overall, Exparel has shown promise in managing post-surgical pain for some patients.36789
Who Is on the Research Team?
Tokunbo I Ayeni, MD
Principal Investigator
United States Naval Medical Center, Portsmouth
Are You a Good Fit for This Trial?
This trial is for patients undergoing their first septorhinoplasty at NMCP or Langley Air Force Base. It's not suitable for individuals with a history of alcohol abuse, opiate use disorder, mental health medication use, or those needing revision surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a regional block with Exparel or injectable saline to the nose during septorhinoplasty
Follow-up
Participants are monitored for opiate use and pain intensity after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
United States Naval Medical Center, Portsmouth
Lead Sponsor