NCT01804114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

January 29, 2021

Completed
Last Updated

January 29, 2021

Status Verified

December 1, 2020

Enrollment Period

3.6 years

First QC Date

February 25, 2013

Results QC Date

September 3, 2019

Last Update Submit

January 11, 2021

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Days With Post-Operative Narcotic Analgesic Use

    Up to 3 weeks post surgery

Other Outcomes (1)

  • Satisfaction With PostOperative Pain Management

    Satisfaction scores reported twice daily for up to the 7th day postoperatively

Study Arms (2)

Local anesthetic continuous infusion

ACTIVE COMPARATOR

Pain management following hernia repair

Procedure: Pain management following hernia repair

Placebo continuous infusion

PLACEBO COMPARATOR

Placebo pain management following hernia repair

Procedure: Placebo for pain management following hernia repair

Interventions

Pain management following hernia repairPROCEDURE

Continuous infusion of local anesthetic via pain pump following hernia repair

Also known as: Placement of pain pump to manage post-operative hernia pain
Local anesthetic continuous infusion
Placebo for pain management following hernia repairPROCEDURE

Continuous infusion of placebo via pain pump following hernia repair

Also known as: Placement of placebo pain pump
Placebo continuous infusion

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • ASA I,II,III
  • Scheduled for Laparoscopic Ventral Hernia Repair

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michael Ujiki, MD
Organization
NSUHS
rpulido@northshore.org
8475701700

Study Officials

  • Michael Ujiki, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Minimally Invasive Surgery

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 5, 2013

Study Start

March 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 29, 2021

Results First Posted

January 29, 2021

Record last verified: 2020-12

Locations

US(1)