OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients

May 16, 2017 updated by: William Beaumont Army Medical Center
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population. Approximately 12 to 15 weight reduction surgeries are performed at William Beaumont Army Medical Center each month. It is the current practice that each patient receiving the laparoscopic gastric sleeve or laparoscopic Roux-en-Y gastric bypass receive an OnQ pain catheter during the surgery to reduce post-operative pain. There have been limited studies to quantify the efficacy of these devices. This study will seek to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79920
        • William Beaumont Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing a gastric sleeve procedure will be offered the opportunity to participate.

Description

Inclusion Criteria:

  • Meets criteria for Bariatric surgery
  • Consents to be in protocol
  • No local anesthetic allergy
  • Will be having sleeve gastrectomy
  • Doesn't have extensive scarring of abdominal wall that would prevent placement of OnQ catheter

Exclusion Criteria:

  • declines to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
receiving lidocaine
Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of 1% lidocaine.
receiving injectable saline
Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of injectable saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic use
Time Frame: from admission to recovery room until discharge from the hospital (3-5 days)
immediate post-operative narcotic use per patient
from admission to recovery room until discharge from the hospital (3-5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Army Medical Center

Investigators

  • Principal Investigator: Gregory Peirce, MD, William Beaumont Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 12, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 371884-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morbid Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe