Continuous Local Anesthetic Infusion Following Hernia Repair

NorthShore University HealthSystem

Status: Completed

Conditions: Ventral Hernia

Treatments: Procedure: Pain management following hernia repair; Procedure: Placebo for pain management following hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01804114

EH11-297

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Local anesthetic continuous infusion

Active Comparator group

Description:

Pain management following hernia repair

Treatment:

Procedure: Pain management following hernia repair

Placebo continuous infusion

Placebo Comparator group

Description:

Placebo pain management following hernia repair

Treatment:

Procedure: Placebo for pain management following hernia repair