PCEA vs IV PCA for Postoperative Pain Management After Liver Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to manage pain after liver surgery by comparing two methods: patient-controlled epidural analgesia (PCEA) and patient-controlled analgesia (IV PCA). The goal is to determine if PCEA, which delivers pain relief through an epidural, is more effective than the standard IV PCA method, where pain medication is delivered through an IV. Individuals undergoing elective liver surgery, without conditions that prevent epidural use, might be suitable for this trial. 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking high-dose opioids or certain opioid medications like Buprenorphine, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that patient-controlled epidural analgesia (PCEA) is generally safe for managing post-surgical pain. Studies have found that PCEA effectively relieves moderate to severe pain, particularly after liver surgery. Specifically, patients using PCEA after open liver surgery reported better pain relief than those using traditional methods.
In terms of safety, PCEA is well-tolerated by most patients. Previous studies have not identified major safety concerns. However, like any treatment, it may cause some side effects, which are usually manageable. This makes PCEA a promising option for post-surgical pain management.12345Why are researchers excited about this trial's treatments?
Researchers are excited about exploring different methods of pain management after liver surgery, particularly by comparing PCEA (Patient-Controlled Epidural Analgesia) with IV PCA (Intravenous Patient-Controlled Analgesia). While IV PCA is a common approach that delivers pain medication through an IV, PCEA offers a direct delivery of anesthesia to the thoracic epidural space, potentially providing more targeted and effective pain relief. This technique could minimize systemic side effects and improve recovery times. By evaluating these two approaches, researchers aim to determine which method offers superior pain control and overall patient outcomes after liver surgery.
What evidence suggests that this trial's treatments could be effective for postoperative pain management after liver surgery?
This trial will compare patient-controlled epidural analgesia (PCEA) with intravenous patient-controlled analgesia (IV PCA) for managing postoperative pain after liver surgery. Research has shown that PCEA might manage pain more effectively than the traditional IV method. Studies have found that patients using epidural pain relief require fewer opioids in the first 72 hours after surgery, leading to better pain control. Additionally, epidural pain relief is effective for surgeries in the abdominal area. While PCEA is safe and promising, further research is needed to fully understand its benefits for patients undergoing liver surgery.14567
Who Is on the Research Team?
Vittoria Arslan-Carlon, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 who can consent and are undergoing elective liver resection for liver disease, including additional surgeries, without contraindications to epidural catheter insertion. Excluded are those with allergies to study drugs, pain at rest or movement (NRS >2), opioid agonist/antagonist use, bleeding disorders, neurological issues, extensive spinal history or deformity, certain pre-op coagulopathy levels or infections at the epidural site.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either patient-controlled epidural analgesia (PCEA) or intravenous patient-controlled analgesia (IV PCA) for post-operative pain control after liver resection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain control assessment using NRS pain score
What Are the Treatments Tested in This Trial?
Interventions
- IV PCA
- PCEA
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor