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

NCT03159130 | Withdrawn

• 1 other identifier: 371884-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity

Keywords

Pain pump catheters; bariatric surgery; OnQ pump; sleeve gastrectomy; continuous infusion catheter

Outcome Measures

Primary Outcomes (1)

• Narcotic use

  immediate post-operative narcotic use per patient

  from admission to recovery room until discharge from the hospital (3-5 days)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• declines to participate

Sponsors & Collaborators

• William Beaumont Army Medical Center: lead

Study Sites (1)

William Beaumont Army Medical Center

El Paso, Texas, 79920, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Peirce, MD

  William Beaumont Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 18, 2017
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)