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PCEA vs IV PCA for Postoperative Pain Management After Liver Surgery
Phase 3
Waitlist Available
Led By Vittoria Arslan-Carlon, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or evidence of infection at potential epidural site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare patient-controlled epidural analgesia (PCEA) to the current standard of care, IV PCA, to see if PCEA is a better method for managing pain after liver resection.
Who is the study for?
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.
What is being tested?
The trial is testing if patient-controlled epidural analgesia (PCEA) manages post-operative pain better than the standard intravenous patient-controlled analgesia (IV PCA) after liver resection surgery. It aims to compare daily pain relief and mobility between these two methods.
What are the potential side effects?
Potential side effects may include reactions to medications like dilaudid, fentanyl, bupivacaine such as itching or rash; complications from catheter placement like infection; and typical anesthesia-related risks such as headaches or low blood pressure.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication that includes opioids.
Select...
I cannot have an epidural due to certain health conditions or medication use.
Select...
I take high doses of pain medication daily (60mg of morphine or more).
Select...
I have severe COPD with less than half the normal lung function.
Select...
I experience pain at rest or when moving that is more than mild.
Select...
I am allergic to dilaudid, fentanyl, or bupivacaine.
Select...
I cannot walk up two flights of stairs without stopping due to my health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ability to detect a 2-point NRS scale difference
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PCEA during and after surgeryExperimental Treatment1 Intervention
general anesthesia with post-operative thoracic epidural analgesia with a standard demand pump
Group II: IV PCA after surgeryActive Control1 Intervention
general anesthesia with post-operative IV PCA with a standard demand pump
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,269 Total Patients Enrolled
1 Trials studying Pain Management
360 Patients Enrolled for Pain Management
Vittoria Arslan-Carlon, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
282 Total Patients Enrolled