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NCT02192879 · ClinicalTrials.gov registry record · NA

TEA vs. PVB vs. PCA in Liver Resection Surgery

A NA study, sponsored by Duke University.

Terminated
Registry status
NA
Development phase
10
Enrollment target

NCT02192879: Clinical Trial NA study, sponsored by Duke University.

NCT02192879 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02192879, a NA study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB may improve recovery and decrease postoperative pain scores in addition to other benefits such earlier return of bowel function and shortened length of hospital stay, although some practitioners have voiced concerns about the safety and efficacy of these techniques in patients after liver resection who may develop postoperative coagulation abnormalities. The investigators plan to enroll a total of 150 patients (adults \>/= 18 years of age who meet study criteria) scheduled for complex liver resection surgery in this study, who will then be randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores will be collected in PACU and throughout the patient's hospital stay as well as routine blood tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also collect additional data prospectively on all patients enrolled in the study; these parameters will include age, sex, type of operation performed, length of operation, volume of intraoperative blood loss, volume of intraoperative fluid administration including blood products, daily postoperative intravenous fluid administration, length of time to first feeding, day of epidural catheter removal, length of hospital stay and incidence of major postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will undergo rigorous statistical analysis using the appropriate statistical techniques to determine the outcomes. The investigators propose that epidural and/or paravertebral an

Primary Outcome

Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain scor

Interventions

  • DEVICE thoracic epidural
  • DEVICE continuous paravertebral catheter
  • DRUG Patient-Controlled Analgesia

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2014-08
Est. Completion 2016-05
Phase NA
Duke University

1,725 total trials

Why NCT02192879 stopped before completion

NCT02192879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which thoracic epidural is the first listed.

NCT02192879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02192879 about?

NCT02192879 is a clinical study titled "TEA vs. PVB vs. PCA in Liver Resection Surgery". This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analges...

What is the current status of trial NCT02192879?

This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2014-08. Estimated completion is 2016-05.

What interventions are being tested in trial NCT02192879?

The interventions under investigation include: thoracic epidural (DEVICE), continuous paravertebral catheter (DEVICE), Patient-Controlled Analgesia (DRUG).

Who is sponsoring clinical trial NCT02192879?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02192879's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02192879, the US trial registry maintained by the National Library of Medicine. NCT02192879 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.