PCEA vs IV PCA for Postoperative Pain Management After Liver Surgery

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byVittoria Arslan-Carlon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.

Research Team

Vittoria Arslan-Carlon, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

I am 18 years or older and can give my consent.

I am having liver surgery for a liver condition or liver cancer, and I can safely have an epidural.

Exclusion Criteria

You have a serious problem with memory or thinking, or you have a documented mental health issue.

I am currently taking medication that includes opioids.

You have cirrhosis, which is a liver condition. If it's found during surgery, you can't be in the study, but you'll still be checked for the study's main goals.

See 6 more

Treatment Details

Interventions

IV PCA (Procedure)
PCEA (Procedure)

Trial OverviewThe 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.

Participant Groups

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