Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06658574

Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients

Led by Rutgers, The State University of New Jersey · Updated on 2025-04-02

150

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

Sponsors

R

Rutgers, The State University of New Jersey

Lead Sponsor

R

Rutgers Robert Wood Johnson Medical School

Collaborating Sponsor

AI-Summary

What this Trial Is About

Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.

CONDITIONS

Official Title

Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years old or greater who meet patient selection criteria for either primary Roux-en-Y gastric bypass or primary laparoscopic sleeve gastrectomy.
Not Eligible

You will not qualify if you...

  • Known allergy or intolerance to acetaminophen or any inactive ingredients in either formulation.
  • Patients unable or uncomfortable taking pills.
  • Patients who had Duodenal Switch surgeries, Adjustable Gastric Banding, surgical revisions, or conversions.
  • Patients with a history of chronic or current pain syndromes.
  • Patients with opioid use disorder indicated by ICD-10 code F11.90.
  • Vulnerable populations including children, prisoners, pregnant women, and mentally disabled persons.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08690

Actively Recruiting

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Research Team

D

Daniel T Abazia, PharmD

CONTACT

M

Mindy Rodden, PhD, RN, CPNP-AC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients | DecenTrialz