Continuous Local Anesthetic Infusion Following Hernia Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Pain management following hernia repair; Procedure: Placebo for pain management following hernia repair

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction With PostOperative Pain Management	Subjects report satisfaction with how pain is managed for the first 7 days postoperatively, on a Numerical Rating Scale of 1-10; higher scores indicate less pain and greater satisfaction. Two daily scores were averaged to compute a single value for each day.	Satisfaction scores reported twice daily for up to the 7th day postoperatively

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Collaborators: Kimberly-Clark Corporation
• Investigators: Principal Investigator: Michael Ujiki, MD, Northshore University Healthsystem

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: EH11-297