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

NCT06658574 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro2023002382
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Post Operative Analgesia; Bariatric Surgery; Bariatric Surgery (Gastric Bypass); Bariatric Surgery Patients; Perioperative Analgesia

Keywords

Acetaminophen; Bariatric; Analgesia; Perioperative; Post Operative

Outcome Measures

Primary Outcomes (1)

• Pain control

  Numeric Rain Scale (The scale has a fixed range with 0 representing "no pain" and the upper limit of 10 representing "worst pain possible")

  From date of consent until the date of hospital discharge, assessed up to 3 months.

Secondary Outcomes (2)

• Length of stay (LOS)

  From date of consent until the date of hospital discharge, assessed up to 3 months

• Milligrams Morphine Equivalents (MME)

  From date of consent until the date of hospital discharge, assessed up to 3 months

Study Arms (2)

Oral acetaminophen - Tablet

EXPERIMENTAL

Acetaminophen 650 mg tablet by mouth

Drug: Acetaminophen

Oral acetaminophen - Liquid

EXPERIMENTAL

Acetaminophen 650 mg liquid by mouth

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Arm 1: Once cleared for oral intake - acetaminophen tablets 650 mg PO every 6 hours PRN - mild pain (1 - 3) to a maximum of 4 grams daily for 3 days\' dispensed as unit-dose tablets Arm 2: Once cleared for oral intake - acetaminophen liquid (160 mg/5 mL) 650 mg PO every 6 hours PRN - mild pain (1 - 3) to a maximum of 4 grams daily for 3 days; 650 mg = 20.3 mL, dispensed as a unit-dose cup

Oral acetaminophen - Liquid; Oral acetaminophen - Tablet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with a known hypersensitivity or history of intolerance to acetaminophen or any inactive ingredients in either formulation. Patients uncomfortable with or unable to take pills.
• Surgical: Duodenal Switch (DS) surgeries, Adjustable Gastric Banding (AGB), surgical revisions, and surgical conversions.
• Medical: patients with documented history of chronic and/or current pain syndrome, as evidenced by documentation of ICD-10 code G89.4, patients with documented ICD-10 code F11.90, indication unspecified, uncomplicated opioid use.
• Patients of vulnerable populations, as outlined by federal guidelines as children, prisoners, pregnant women, and mentally disabled persons will be excluded.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Rutgers Robert Wood Johnson Medical School: collaborator

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08690, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Daniel T Abazia, PharmD, BCPS, CPPS

  Rutgers University - Ernest Mario School of Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel T Abazia, PharmD

CONTACT

773-633-5215; dabazia@pharmacy.rutgers.edu

Mindy Rodden, PhD, RN, CPNP-AC

CONTACT

732-418-8078; minnette.markus-rodden@rwjbh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 26, 2024
• Study Start: November 13, 2024
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)