This study will compare the clinical performance of the SEMPERFLO\* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures. \*Trademark
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
continuous infusion of 0.5% bupivacaine at 2mL per hour
continuous infusion of 0.5% bupivacaine at 2mL per hour
Boca Raton Community Hospital
Boca Raton, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Washington University
St Louis, Missouri, United States
Universtiy of Tennessee
Knoxville, Tennessee, United States
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
Time frame: twenty-four hours post procedure
Narcotic and non-narcotic analgesic usage
Time frame: 24, 48, 72, 96 and 120 hours post- procedure
Numeric pain scale scores at rest and with coughing
Time frame: 24, 48, 72, 96, and 120 hours post-procedure
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North Texas Surgery Center
Dallas, Texas, United States
Michale E. DeBakey VA Medical Center
Houston, Texas, United States