MedTrace Logo

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

NCT06658574 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-02

No results posted yet for this study

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

Interventions

DRUG

Acetaminophen

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

Sponsors & Collaborators

  • Rutgers Robert Wood Johnson Medical School

    collaborator OTHER

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Daniel T Abazia, PharmD, BCPS, CPPS · Rutgers University - Ernest Mario School of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2026-02-28
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658574 on ClinicalTrials.gov