Inguinal Hernia, Pain
Conditions
Brief summary
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
Detailed description
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.
Interventions
DEVICESEMPERFLO Pain Management System
continuous infusion of 0.5% bupivacaine at 2mL per hour
continuous infusion of 0.5% bupivacaine at 2mL per hour
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure * Subject is 18 years or older * Subject must be willing to participate in the study, and provide informed consent to participate.
Exclusion criteria
* Subjects undergoing recurrent hernia repair; * Subjects who plan to undergo another elective surgical procedure prior to the completion of this study; * Subjects with known allergy to bupivacaine; * Subjects with immunodeficiency diseases (including known HIV); * Subjects with any findings identified by the surgeon that may preclude conduct of the study; * Subjects who are known current alcohol and/or drug abusers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale | twenty-four hours post procedure |
Secondary
| Measure | Time frame |
|---|---|
| Narcotic and non-narcotic analgesic usage | 24, 48, 72, 96 and 120 hours post- procedure |
| Numeric pain scale scores at rest and with coughing | 24, 48, 72, 96, and 120 hours post-procedure |
Countries
United States
Outcome results
None listed