A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02233400|
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Bariatric surgery is the only proven and effective long term treatment for morbid obesity. In an attempt to reduce patients' post-operative hospital stay, lower associated health care costs, and improve satisfaction scores, St Luke's University Health Network (SLUHN) recently adopted a fast track bariatric surgery (FTBS) protocol. Findings to date show that FTBS is safe and effective when performed in a Center of Excellence (COE) such as ours. However, post-operative pain control remains a challenging issue, with only intravenous (IV) or PO (by mouth) narcotics appropriate for bariatric surgery patients.
IV acetaminophen, which has been used successfully in Europe, was recently approved by the Federal Drug Administration (FDA) for use in the US. However, no data exist regarding the use of IV acetaminophen in bariatric surgery patients, nor are there any data assessing its cost effectiveness. Therefore, our study will investigate the economic impact of administering IV acetaminophen to bariatric surgery patients, as well as its effect on clinical outcomes such as patients' post-operative length of stay, self-reported pain, readmissions, emergency room (ER) visits and complications.
The study design will be a randomized, double-blind, parallel-group, controlled trial in a single bariatric Center of Excellence (COE) that is part of the St. Luke's University Health Network (SLUHN). Patients will consist of up to 200 morbidly obese adult bariatric surgery candidates > 18 years of age undergoing either laparoscopic Roux-en-Y Gastric Bypass (LRYGB) or laparoscopic Sleeve Gastrectomy (LSG). Group 1 (treatment) will receive IV acetaminophen plus IV narcotics for the first 6 hours post-surgery followed by IV/ PO narcotics for the remaining 18 hours. Group 2 (control) will receive IV normal saline plus IV narcotics for the first 6 hours post-surgery followed by IV/PO narcotics for the remaining 18 hours. Data analysis will include quantile regression, mixed randomized-repeated analysis of covariance (ANCOVA) and selected univariate comparisons, with p < .05 denoting statistical significance for all outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Hospital Costs Length of Stay Postoperative Pain Score Patient Satisfaction||Drug: Acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: A Double-Blind Prospective Randomized Trial in A Single Accredited Bariatric Center|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||July 2014|
Group 1 (treatment) will receive IV acetaminophen (1g in 100 ml of 0.9% normal saline IV Q 6hrs for 24 hours) plus IV narcotics (2-4 mg IV Q2hrs PRN) for the first 6 hours post-surgery followed by IV narcotics (2-4 mg IV Q2hrs PRN)/ PO narcotics (Oxycodone 5-10 ml PO Q4 hrs PRN) for the remaining 18 hours.
Group 1 (treatment) will receive IV acetaminophen (intervention drug) (1g in 100 ml of 0.9% normal saline IV Q 6hrs for 24 hours) plus IV narcotics (2-4 mg IV Q2hrs PRN) for the first 6 hours post-surgery followed by IV narcotics (2-4 mg IV Q2hrs PRN)/ PO narcotics (Oxycodone 5-10 ml PO Q4 hrs PRN) for the remaining 18 hours.
No Intervention: Control
Group 2 (control) will receive IV normal saline (100 ml of 0.9% normal saline IV Q 6hrs for 24 hours) plus IV narcotics (2-4 mg IV Q2hrs PRN) for the first 6 hours post-surgery followed by IV narcotics (2-4 mg IV Q2hrs PRN)/ PO narcotics (Oxycodone 5-10 ml PO Q4 hrs PRN) for the remaining 18 hours.
- Pain Scale [ Time Frame: 24 hours ]
- length of stay [ Time Frame: less than or greater than 24 hours ]
- Direct Hospital Costs [ Time Frame: 6 months ]
- Patient Satisfaction [ Time Frame: 10 days ]
- ER visits [ Time Frame: 30 days ]
- Indirect Hospital Costs [ Time Frame: 24 to 48 hours ]
- Readmissions [ Time Frame: 30 days ]
- Complications [ Time Frame: 30 days ]
- Amount of narcotics used [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233400
|United States, Pennsylvania|
|St Luke's University Hospital|
|Allentown, Pennsylvania, United States, 18104|
|St Luke's University Health Network|
|Bethlehem, Pennsylvania, United States, 18015|
|Principal Investigator:||Maher El Chaar, MD||St Luke's University Hospital and Health Network|