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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 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 10 participants.
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
Interventions
- DEVICE thoracic epidural
- DEVICE continuous paravertebral catheter
- DRUG Patient-Controlled Analgesia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02192879
The ClinicalTrials.gov registry entry for NCT02192879 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which thoracic epidural is the first listed.
NCT02192879 reports 0 study locations.
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.
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