Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection

Background: A number of studies evaluating unilateral continuous paravertebral block
demonstrate equal or superior analgesia when compared to epidural analgesia for
postoperative pain control (1-7). At the same time, these studies show a decreased incidence
of side effects and complications, including: hypotension, pulmonary complications, urinary
retention, nausea and vomiting and failed blocks. Several studies also indicate that
bilateral paravertebral blocks provide adequate postoperative analgesia (8-14). However, no
study has been performed to date that shows a direct comparison between epidural and
bilateral paravertebral blocks in patients undergoing open liver resection.Objectives: This
prospective, randomized study is intended to assess the efficacy and safety of bilateral
continuous paravertebral blocks compared to continuous epidural block for open liver
resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in
controlling the perioperative pain; and 2) safe, with less frequent complications following
open liver resection when compared to continuous epidural block.Methods: A hundred adult
patients undergoing elective open liver resection will be randomized to receive a continuous
epidural block or continuous bilateral paravertebral blocks for perioperative analgesia. The
primary outcome will be the degree of pain control measured by visual analog scale at 24
hours post surgery (at rest and while the patient is performing maximum incentive
spirometry). The secondary outcomes will include: 1) Assessment of pain (at rest, with
cough, and with ambulation) using the verbal numerical pain scale will be performed
postoperatively every 8 hours by floor nursing staff until discharge. During the night the
patient will not be awakened for pain assessment. 2) Intravenous opioid requirement: In
addition to pain score, postoperative intravenous opioid requirements [hydromorphone (mg)]
will also be recorded daily; Frequency of side effects and complications; and other
functional status (volume of maximum incentive spirometry, time to extubation, total time
for initial ambulation, the length of the hospital stay, time to return of bowel function,
readiness for discharge from the hospital, and length of hospital stay). At one month post
surgery, health-related quality of life, mortality, and any morbidities will be assessed.
Each variable will be compared between the paravertebral group and the epidural group to
examine the hypotheses above. Clinical Implications: Bilateral continuous paravertebral
blocks could be an equally effective and safe alternative to a continuous epidural block for
perioperative pain management in patients who undergo open liver resection.

Inclusion Criteria:

- American Society of Anesthesiologists physical status (ASAPS) I to III patients aged
over 18 years and scheduled to undergo elective open liver resection at UPMC
Presbyterian/Montefiore Hospital will be screened for enrollment in the study. One
hundred (100) patients will be enrolled in this study with equal numbers (n = 50) in
each arm of the trial. In order to avoid skewed sex difference between the two
groups, the sex will be allocated.

Exclusion Criteria:

- non elective surgery,

- ASAPS IV or greater,

- age younger than 18 years,

- any contraindication to the placement of an epidural catheter or bilateral
paravertebral catheters

- chronic pain conditions

- preoperative opioid use

- coagulation abnormalities or patients who are expected to be on therapeutic
anticoagulants postoperatively

- allergy to any of the drugs/agents used our study protocol

- preoperative chronic renal dysfunction, who requires renal replacement therapy or
serum creatinine greater than 1.4 mg/dL

- altered mental status (not oriented to place, person, or time),

- any comorbid conditions that, in the judgment of the consulting surgeon or
anesthesiologist, would proscribe the patient from any aspect of the study, -

- inability to provide adequate informed consent

- refusal to participate in the study.