PCEA vs IV PCA for Postoperative Pain Management After Liver Surgery

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: High dose opioids, Buprenorphine

Disqualifiers: Severe COPD, Cognitive impairment, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Post-operative period

231 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment PCEA vs IV PCA for postoperative pain management after liver surgery?

Research shows that patient-controlled epidural analgesia (PCEA) provides better pain relief than intravenous patient-controlled analgesia (IV PCA) after liver surgery, with lower pain intensity reported in the first three days after surgery. ^{1 2 3 4 5}

Is it safe to use IV PCA or PCEA for pain management after liver surgery?

Both IV PCA (intravenous patient-controlled analgesia) and PCEA (patient-controlled epidural analgesia) have been studied for safety in managing pain after liver surgeries. While both methods are generally considered safe, some studies noted that patients using IV PCA reported more frequent adverse effects compared to those using PCEA. ^{1 2 3 4 6}

How does PCEA differ from IV PCA for managing postoperative pain after liver surgery?

PCEA (patient-controlled epidural analgesia) is unique because it delivers pain relief directly to the area around the spinal cord, providing more targeted pain control compared to IV PCA (intravenous patient-controlled analgesia), which delivers medication through the bloodstream. Studies suggest that PCEA may result in lower pain intensity and fewer adverse effects after liver surgery compared to IV PCA. ^{1 2 3 4 7}

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 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either patient-controlled epidural analgesia (PCEA) or intravenous patient-controlled analgesia (IV PCA) for post-operative pain control after liver resection

Post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain control assessment using NRS pain score

1 year

Treatment Details

Interventions

• IV PCA
• PCEA

Trial Overview 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.

Participant Groups

Group I: PCEA during and after surgery Experimental Treatment 1 Intervention

general anesthesia with post-operative thoracic epidural analgesia with a standard demand pump

Group II: IV PCA after surgery Active Control 1 Intervention

general anesthesia with post-operative IV PCA with a standard demand pump

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Epidural analgesia provides better pain management after live liver donation: a retrospective study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Randomized controlled study comparing the analgesic effects of intravenous patient-controlled analgesia and patient-controlled epidural analgesia after open major surgery for pancreatobiliary cancer. [2022]

3. Lebanon pubmed.ncbi.nlm.nih.gov

Comparison between intravenous patient controlled analgesia and patient controlled epidural analgesia in cirrhotic patients after hepatic resection. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intravenous Patient-controlled Analgesia Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Retrospective Comparison of Three Patient-Controlled Analgesic Strategies: Intravenous Opioid Analgesia Plus Abdominal Wall Nerve Blocks versus Epidural Analgesia versus Intravenous Opioid Analgesia Alone in Open Liver Surgery. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery. [2022]

7. Georgia (Republic) pubmed.ncbi.nlm.nih.gov

COMPARISON OF THE PATIENT-CONTROLLED EPIDURAL AND INTRAVENOUS ANALGESIA AFTER OPEN COLORECTAL SURGERY: A RANDOMIZED CONTROLLED TRIAL. [2021]