Continuous Local Anesthetic Infusion Following Hernia Repair

Study Overview
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Brief Summary
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The primary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower incidence of pain than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower utilization of narcotic analgesic medication than those patients treated with the placebo, saline-filled pain pump.

Detailed Description
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Patients will be screened to determine study eligibility using inclusion/exclusion criteria. Following the consent process, subjects will be randomly assigned to a treatment arm (anesthetic or placebo group). Baseline data will be collected prior surgical implantation of the pain pump delivery system. Both study and control groups will be able to receive supplemental medication for breakthrough pain as determined by the surgeon. Post-operative data will be collected up to three weeks following surgery.

Official Title
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Continuous Preperitoneal Infusion of Local Anesthetic Via Pain Pump for Laparoscopic Ventral Hernia Repair

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: Pain management following hernia repair
* Procedure: Placebo for pain management following hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years ASA I,II,III Scheduled for Laparoscopic Ventral Hernia Repair Exclusion Criteria: ASA IV or greater Needing emergency surgery Known history of drug abuse GI, liver, kidney or other condition which, per the surgeon's opinion, could interfere with the absorption, distribution, metabolism or excretion of any drug used during the duration of the study Patients with a prior allergic reaction or dependency to morphine, demerol, dilaudid, fentanyl, marcaine(bupivicaine), lidocaine, or ropivicaine.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local anesthetic continuous infusion<br>Pain management following hernia repair | Procedure: Pain management following hernia repair<br>* Continuous infusion of local anesthetic via pain pump following hernia repair<br>* Other names: Placement of pain pump to manage post-operative hernia pain;|
| Placebo Comparator: Placebo continuous infusion<br>Placebo pain management following hernia repair | Procedure: Placebo for pain management following hernia repair<br>* Continuous infusion of placebo via pain pump following hernia repair<br>* Other names: Placement of placebo pain pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Pain | Patients will self-report pain assessments on questionnaires each of the first seven days post-operatively using the 4 Point Verbal Rating Scale; ranging from 1=Severe Pain, to 4=No Pain, higher scores indicating less pain, or a better outcome. Values for two daily scores were averaged for each participant, the average across 7 days is reported. | Verbal Rating Scale used twice a day, up to 7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days With Post-Operative Narcotic Analgesic Use | Patients given a diary to record all narcotics taken post-op for pain control. | Up to 3 weeks post surgery |