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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Luke's Hospital and Health Network, Pennsylvania
• Treatments: Acetaminophen; Narcotics; Oxycodone

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