Long-Lasting Pain Relief for Postoperative Pain in Bariatric Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates long-lasting pain relief for individuals undergoing bariatric surgery, which addresses severe obesity. It compares two treatments: standard bupivacaine, which eases pain for about 6 hours, and liposomal bupivacaine, a long-acting local anesthetic that may last up to 72 hours. The researchers aim to determine if the longer-lasting version can better manage pain during the critical days after surgery. Individuals undergoing a laparoscopic sleeve gastrectomy at the Children's Hospital of Richmond, without a bupivacaine allergy, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Do I need 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 liposomal bupivacaine, also known as Exparel, is generally safe and well-tolerated. In one study, patients who received liposomal bupivacaine experienced manageable pain, with levels decreasing over several days. Importantly, this research reported no side effects.
Another review found that liposomal bupivacaine was as safe as standard treatments and sometimes more effective for managing post-surgery pain. This formulation is designed to provide pain relief for up to 72 hours, longer than traditional bupivacaine.
Overall, previous studies have demonstrated a good safety record for liposomal bupivacaine. For those considering participation, this evidence suggests it is a promising option for managing post-surgery pain with minimal risk of side effects.12345Why do researchers think this study treatment might be promising for postoperative pain?
Researchers are excited about liposomal bupivacaine because it offers a potentially longer-lasting solution for managing postoperative pain in bariatric surgery. Unlike standard bupivacaine, which provides short-term relief, liposomal bupivacaine is designed to release the anesthetic slowly over time, extending pain relief duration. This extended-release mechanism can lead to less frequent dosing and possibly reduce the need for opioid pain medications, which is a significant advantage in managing postoperative recovery.
What evidence suggests that this trial's treatments could be effective for postoperative pain in bariatric surgery?
Research has shown that liposomal bupivacaine, which participants in this trial may receive, can relieve pain longer than regular bupivacaine. Studies have found it significantly reduces pain 24, 48, and 72 hours after surgery. Additionally, patients using liposomal bupivacaine often require fewer opioids for pain management post-surgery. Specifically, one study found that 41.3% of patients didn't need any narcotics at home. This suggests that liposomal bupivacaine could be a more effective way to manage post-surgical pain. Meanwhile, another group in this trial will receive standard bupivacaine as the active comparator.678910
Who Is on the Research Team?
Jason Sulkowski
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
This trial is for teens (13-2018 years old) with severe obesity undergoing laparoscopic sleeve gastrectomy at the Children's Hospital of Richmond at VCU. Participants must understand English or Spanish and not have allergies to bupivacaine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Immediate Post-operative Care
Participants undergo bariatric surgery and receive either standard bupivacaine or liposomal bupivacaine for pain control
Post-operative Monitoring
Participants' pain scores and opioid use are monitored on post-operative days 0, 1, 2, and 3
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Liposomal Bupivacaine
- Standard Bupivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor