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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03159130
Other study ID # 371884-1
Secondary ID
Status Withdrawn
Phase N/A
First received May 12, 2017
Last updated May 16, 2017
Start date June 2012
Est. completion date June 2014

Study information

Verified date May 2017
Source William Beaumont Army Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States William Beaumont Army Medical Center El Paso Texas

Sponsors (1)

Lead Sponsor Collaborator
William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Narcotic use immediate post-operative narcotic use per patient from admission to recovery room until discharge from the hospital (3-5 days)
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