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A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02233400
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Maher El Chaar, MD, St. Luke's Hospital and Health Network, Pennsylvania

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
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.
Drug: Acetaminophen
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.



Primary Outcome Measures :
  1. Pain Scale [ Time Frame: 24 hours ]
  2. length of stay [ Time Frame: less than or greater than 24 hours ]
  3. Direct Hospital Costs [ Time Frame: 6 months ]
  4. Patient Satisfaction [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. ER visits [ Time Frame: 30 days ]
  2. Indirect Hospital Costs [ Time Frame: 24 to 48 hours ]
  3. Readmissions [ Time Frame: 30 days ]
  4. Complications [ Time Frame: 30 days ]
  5. Amount of narcotics used [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18
  • attendance at an informational seminar and support group
  • clearance for surgery by a registered dietician and certified social worker
  • BMI > 35 with at least one co-morbid condition (e.g., hypertension, diabetes mellitus, sleep apnea, hypercholesterolemia) or BMI > 40 without any co-morbid conditions
  • negative pregnancy test
  • American Society of Anesthesiology score 1-3
  • ability to understand instructions and comply with all study requirements
  • preoperative %excess weight loss (%EWL) of 3-10%
  • no contraindication for a LRYGB or LSG based on upper endoscopy findings
  • preoperative cardiac consultation for risk stratification
  • evaluation by a sleep medicine specialist to identify risk factors for sleep apnea, with treatment as deemed appropriate

Exclusion Criteria:

  • revisional surgery
  • conversion to open procedure
  • chronic musculoskeletal pain
  • narcotics or NSAIDs use in the 7 days prior to surgery
  • history of fibromyalgia
  • sensitivity to acetaminophen or liver disease (i.e., elevated LFT or history of hepatitis or liver failure)
  • use of monoamine oxidase inhibitor in the 7 days prior to surgery
  • use of any medication containing acetaminophen
  • allergy to morphine or oxycodone

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
St Luke's University Hospital
Allentown, Pennsylvania, United States, 18104
St Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania
Investigators
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Principal Investigator: Maher El Chaar, MD St Luke's University Hospital and Health Network

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Responsible Party: Maher El Chaar, MD, Clinical Assistant Professor of Surgery, Co-Medical Director Bariatric Surgery, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT02233400    
Other Study ID Numbers: SLHN 2012-102
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by Maher El Chaar, MD, St. Luke's Hospital and Health Network, Pennsylvania:
Acetaminophen
Gastric Bypass
Sleeve Gastrectomy
Pain
Cost
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Oxycodone
Narcotics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Central Nervous System Depressants