Liposomal Bupivacaine for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Exparel (a formulation of liposomal bupivacaine), when combined with bupivacaine and injected before a minimally invasive total hysterectomy, reduces pain more effectively than bupivacaine alone. Participants will monitor their pain levels and pain medication use. The trial targets patients undergoing this specific surgery without an anesthetic block and who have not recently used certain pain medications or experienced specific medical conditions. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking certain medications before the trial. Specifically, you must not use opioids, SSRIs, tricyclic antidepressants, gabapentin, or pregabalin within three days of surgery, and acetaminophen within 24 hours of surgery.
What is the safety track record for these treatments?
Research has shown that liposomal bupivacaine, also known as Exparel, is generally safe. Studies have found it to be well-tolerated, with no major side effects reported. For example, one study found that patients experienced low pain levels after surgery without any side effects, suggesting the treatment is likely safe.
Exparel is already approved for managing pain, which supports its safety. When combined with bupivacaine, it helps reduce post-surgery pain. Traditional bupivacaine, used in the control group of the trial, is also widely used and considered safe.
Overall, previous research has demonstrated the safety of both treatments in the trial. Participants can feel reassured about the safety of these options based on existing evidence.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the use of liposomal bupivacaine, particularly Exparel, for managing postoperative pain because it offers a prolonged pain relief effect. Unlike traditional bupivacaine, which typically provides pain relief for just a few hours, Exparel's liposomal formulation extends its action to potentially last up to 72 hours. This longer duration can mean fewer doses and less reliance on opioids, which are standard for pain management but come with significant side effects and addiction risks. Additionally, the combination of Exparel with bupivacaine could offer enhanced pain control, providing patients with a more comfortable recovery period after surgery.
What evidence suggests that this trial's treatments could be effective for postoperative pain?
In this trial, participants will join different treatment groups to evaluate postoperative pain management. Research has shown that Exparel, one of the treatments in this trial, is safe and can reduce the need for opioids after surgery. Some studies found it provides similar or better pain relief compared to regular bupivacaine, another treatment option in this trial. However, other research suggests Exparel might not always control pain better than regular bupivacaine. In some cases, regular bupivacaine worked better for pain relief. Overall, Exparel's effectiveness in reducing pain can vary depending on the specific medical situation.15678
Who Is on the Research Team?
Scott Chudnoff, MD
Principal Investigator
MMC
Are You a Good Fit for This Trial?
This trial is for patients over 18 years old undergoing minimally invasive hysterectomy without prior anesthetic blocks. It excludes those who've recently used opioids, certain antidepressants, or pain medications; have significant medical risks; concurrent painful conditions; history of hepatitis (except A); allergies to specific anesthetics or propofol; recent or planned participation in other drug trials; uncontrolled psychiatric disorders; chronic analgesic use.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Exparel mixed with bupivacaine or bupivacaine only injected into the vaginal cuff before minimally invasive hysterectomy
Immediate Postoperative Monitoring
Pain severity is assessed preoperatively, at PACU arrival, and at 1 hour postoperatively using a VAS scale
Follow-up
Participants are monitored for pain and opioid use at 12, 24, 48, and 72 hours postoperatively through phone conversations
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
- Exparel with Bupivacaine
Bupivacaine is already approved in United States, European Union, Canada for the following indications:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maimonides Medical Center
Lead Sponsor