A prospective, randomized, blinded study of continuous ropivacaine infusion in
the median sternotomy incision following cardiac surgery.
Author(s): Agarwal S(1), Nuttall GA, Johnson ME, Hanson AC, Oliver WC Jr.
Affiliation(s): Author information:
(1)Department of Anesthesiology, Detroit Medical Center, Detroit, MI, USA.
Publication date & source: 2013, Reg Anesth Pain Med. , 38(2):145-50
OBJECTIVE: The aim of this prospective, randomized, double-blind, placebo
controlled trial was to evaluate the safety and efficacy of continuous
ropivacaine infusion of into the sternal wound.
METHODS: We planned to enroll 200 patients scheduled for various cardiac surgical
procedures into the study. Patients, in a double-blind randomized fashion, were
given either normal saline or 0.3% ropivacaine through 2 subcutaneous multiport
catheters placed on either side of the sternal split at an infusion rate of 4
mL/h for 64 hours. The efficacy outcomes measured were time to extubation of the
trachea, intensive care unit and hospital stay duration, pain scores, and
narcotic usage. The safety outcomes measured were systemic local anesthetic
toxicity, major cardiac complications, and wound infection.
MEASUREMENTS AND MAIN RESULTS: The data safety monitoring board stopped the study
after enrolling 85 patients because of excessive sternal wound infections (9%, n
= 44) in the ropivacaine group. This rate of infection was not statistically
different from the control group (0%, n = 41, P = 0.12), but it was statistically
different from our historical incidence of sternal wound infection (1.9%, no =
6381, P = 0.002). There was also a lack of evidence of efficacy for time to
extubation of the trachea, narcotic usage, and pain control.
CONCLUSIONS: The phase III trial did not show improvement in time to extubation
of the trachea or pain control in the 0.3% ropivacaine group, but it was stopped
early by the data safety monitoring board.
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