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

NCT ID: NCT03159130

Last Updated: 2017-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Peirce, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Army Medical Center

Locations

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William Beaumont Army Medical Center

El Paso, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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371884-1

Identifier Type: -

Identifier Source: org_study_id

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