TEA vs. PVB vs. PCA in Liver Resection Surgery



Status:Recruiting
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:August 2014

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A Comparison of the Efficacy of Alternative Analgesia Modalities in Complex Hepatic Resection Surgery: Thoracic Epidural Analgesia Versus Continuous Paravertebral Block With Patient-Controlled Analgesia Versus Patient-Controlled Analgesia

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 analgesia may improve recovery times and decrease
hospital length of stay, which would be beneficial for the patient as well as decrease
hospital costs. In addition, if better postoperative pain management scores can be achieved
with epidural or paravertebral analgesia, and no significant prolonged postoperative
coagulopathy is associated with patients undergoing major hepatic resection surgical
procedures, these regional analgesia strategies can be considered a safe option for pain
management in this patient population.


Inclusion Criteria:

- Age >/= 18 years and
- Scheduled for elective hepatic resection surgery

Exclusion Criteria:

- Preexisting coagulopathy (INR >1.5)

- Spinal stenosis

- Local infection in area where catheter will be inserted

- Severe cardiovascular disease (NYHA Class III/IV)

- Severe pulmonary disease (FEV1 <50% of predicted value)

- Allergy or sensitivity to narcotics or local anesthetics

- BMI >45

- Inability to give informed consent
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Amy Manchester, MD
Phone: 919-423-0884
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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