NCT01804114

Continuous Local Anesthetic Infusion Following Hernia Repair

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Ventral Hernia

Interventions

Type	Name	Description
PROCEDURE	Pain management following hernia repair	Continuous infusion of local anesthetic via pain pump following hernia repair
PROCEDURE	Placebo for pain management following hernia repair	Continuous infusion of placebo via pain pump following hernia repair

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-03-05
• Last updated: 2021-01-29
• Results posted: 2021-01-29

Locations

1 site across 1 country: United States