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Continuous Local Anesthetic Infusion Following Hernia Repair

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain management following hernia repair
Placebo for pain management following hernia repair
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Local anesthetic continuous infusion

Placebo continuous infusion

Arm Description

Pain management following hernia repair

Placebo pain management following hernia repair

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Days With Post-Operative Narcotic Analgesic Use
Patients given a diary to record all narcotics taken post-op for pain control.

Full Information

First Posted
February 25, 2013
Last Updated
January 11, 2021
Sponsor
NorthShore University HealthSystem
Collaborators
Kimberly-Clark Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01804114
Brief Title
Continuous Local Anesthetic Infusion Following Hernia Repair
Official Title
Continuous Preperitoneal Infusion of Local Anesthetic Via Pain Pump for Laparoscopic Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Kimberly-Clark Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthetic continuous infusion
Arm Type
Active Comparator
Arm Description
Pain management following hernia repair
Arm Title
Placebo continuous infusion
Arm Type
Placebo Comparator
Arm Description
Placebo pain management following hernia repair
Intervention Type
Procedure
Intervention Name(s)
Pain management following hernia repair
Other Intervention Name(s)
Placement of pain pump to manage post-operative hernia pain
Intervention Description
Continuous infusion of local anesthetic via pain pump following hernia repair
Intervention Type
Procedure
Intervention Name(s)
Placebo for pain management following hernia repair
Other Intervention Name(s)
Placement of placebo pain pump
Intervention Description
Continuous infusion of placebo via pain pump following hernia repair
Primary Outcome Measure Information:
Title
Post-Operative Pain
Description
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.
Time Frame
Verbal Rating Scale used twice a day, up to 7 days postoperatively
Secondary Outcome Measure Information:
Title
Number of Days With Post-Operative Narcotic Analgesic Use
Description
Patients given a diary to record all narcotics taken post-op for pain control.
Time Frame
Up to 3 weeks post surgery
Other Pre-specified Outcome Measures:
Title
Satisfaction With PostOperative Pain Management
Description
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.
Time Frame
Satisfaction scores reported twice daily for up to the 7th day postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ujiki, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

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Continuous Local Anesthetic Infusion Following Hernia Repair

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