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

NCT02233400 | Completed Phase 4

• 1 other identifier: SLHN 2012-102
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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.

Conditions

Hospital Costs; Length of Stay; Postoperative Pain Score; Patient Satisfaction

Keywords

Acetaminophen; Gastric Bypass; Sleeve Gastrectomy; Pain; Cost

Outcome Measures

Primary Outcomes (4)

• Pain Scale

  24 hours

• length of stay

  less than or greater than 24 hours

• Direct Hospital Costs

  6 months

• Patient Satisfaction

  10 days

Secondary Outcomes (5)

• ER visits

  30 days

• Indirect Hospital Costs

  24 to 48 hours

• Readmissions

  30 days

• Complications

  30 days

• Amount of narcotics used

  24 hours

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Acetaminophen DRUG

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.

Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Hospital and Health Network, Pennsylvania: lead

Study Sites (2)

St Luke's University Hospital

Allentown, Pennsylvania, 18104, United States

Location

St Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Patient Satisfaction; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Maher El Chaar, MD

  St Luke's University Hospital and Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Surgery, Co-Medical Director Bariatric Surgery

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: September 8, 2014
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

US (2)