MedPath

Continuous Local Anesthetic Infusion Following Hernia Repair

Not Applicable
Completed
Conditions
Ventral Hernia
Interventions
Procedure: Pain management following hernia repair
Procedure: Placebo for pain management following hernia repair
Registration Number
NCT01804114
Lead Sponsor
NorthShore University HealthSystem
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Local anesthetic continuous infusionPain management following hernia repairPain management following hernia repair
Placebo continuous infusionPlacebo for pain management following hernia repairPlacebo pain management following hernia repair
Primary Outcome Measures
NameTimeMethod
Post-Operative PainVerbal Rating Scale used twice a day, up to 7 days postoperatively

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.

Secondary Outcome Measures
NameTimeMethod
Number of Days With Post-Operative Narcotic Analgesic UseUp to 3 weeks post surgery

Patients given a diary to record all narcotics taken post-op for pain control.

Trial Locations

Locations (1)

NorthShore University HealthSystem

🇺🇸

Evanston, Illinois, United States

© Copyright 2025. All Rights Reserved by MedPath