Continuous Local Anesthetic Infusion Following Hernia Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-10-31

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.

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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.

Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Local anesthetic continuous infusion

Pain management following hernia repair

Group Type ACTIVE_COMPARATOR

Pain management following hernia repair

Intervention Type PROCEDURE

Continuous infusion of local anesthetic via pain pump following hernia repair

Placebo continuous infusion

Placebo pain management following hernia repair

Group Type PLACEBO_COMPARATOR

Placebo for pain management following hernia repair

Intervention Type PROCEDURE

Continuous infusion of placebo via pain pump following hernia repair

Interventions

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Pain management following hernia repair

Continuous infusion of local anesthetic via pain pump following hernia repair

Intervention Type PROCEDURE

Placebo for pain management following hernia repair

Continuous infusion of placebo via pain pump following hernia repair

Intervention Type PROCEDURE

Other Intervention Names

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Placement of pain pump to manage post-operative hernia pain Placement of placebo pain pump

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No