R.E.C.K vs Exparel for Pain Management
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two pain management treatments, R.E.C.K (a new potential drug) and Exparel, for patients undergoing robotic kidney surgery. Researchers aim to determine which treatment better controls pain, reduces the need for additional pain medications, and affects hospital stay length. The goal is to assess whether the cost of Exparel is justified compared to R.E.C.K. Patients planning to undergo robotic kidney surgery and not on chronic opioid medications might be suitable candidates for this study. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using chronic opioids, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Exparel, a treatment for managing pain, has generally been well-tolerated in past studies. The most common side effects include stomach pain, irritation at the injection site, and headaches. Some individuals have also reported nervousness or stomach issues, indicating potential stomach upset. However, one study found that people using Exparel experienced fewer issues such as difficulty urinating, slow breathing, and risk of falling.
R.E.C.K is currently being tested in a Phase 3 trial, indicating some safety information from earlier stages. At this point, treatments are usually considered safe enough for larger groups. However, specific side effects and detailed safety data for R.E.C.K are not available in the sources. While R.E.C.K has likely been safe enough to reach this trial phase, more detailed safety information may become available as the trial progresses.12345Why do researchers think this study treatment might be promising?
Most treatments for pain management, like opioids or local anesthetics such as bupivacaine, work by blocking nerve signals to reduce pain. However, R.E.C.K. offers a fresh approach by utilizing a novel mechanism that specifically targets pain pathways, potentially leading to more effective pain relief with fewer side effects. Researchers are excited about R.E.C.K. because it could provide a more precise and controlled method of managing pain, reducing the need for traditional painkillers that often come with significant side effects and risks.
What evidence suggests that this trial's treatments could be effective for pain management?
This trial will compare R.E.C.K and Exparel for post-surgery pain management. Research shows both treatments are effective, but they work in slightly different ways. Participants may receive R.E.C.K, a combination of ropivacaine, epinephrine, clonidine, and ketorolac, which significantly reduces pain at 2, 4, 6, and 12 hours after surgery. Alternatively, participants may receive Exparel, a type of bupivacaine designed for slow release, which effectively reduces the need for opioid painkillers post-surgery. However, some studies suggest it may not always surpass other pain relief methods. Both treatments show promise for managing post-surgery pain, but R.E.C.K may provide quicker relief.678910
Who Is on the Research Team?
Roy Ornob, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for individuals undergoing robotic partial or radical nephrectomy due to kidney cancer. Participants should be able to rate their pain using the Numerical Rating Score and must not have any conditions that would exclude them from safely receiving the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either R.E.C.K or Exparel intraoperatively during robotic nephrectomy
Postoperative Monitoring
Participants are monitored for pain scores, opioid intake, and length of stay during inpatient stay
Follow-up
Participants are monitored for adverse events and pain management post-discharge
What Are the Treatments Tested in This Trial?
Interventions
- Exparel
- R.E.C.K
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Atrium Health Levine Cancer Institute
Collaborator