Using acetaminophen for pain management after bariatric surgery
Comparative Efficacy of Two Different Oral Dosage Forms of Acetaminophen for Post-operative Analgesia in Bariatric Surgery Patients
This study is testing whether liquid or pill forms of acetaminophen work better for managing pain after weight loss surgery in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT06658574 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of liquid versus pill formulations of acetaminophen for managing post-operative pain in adults who have undergone Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. It aims to understand how these patients metabolize acetaminophen due to changes in their anatomy and physiology after surgery. By assessing both subjective and objective measures of pain control, the study seeks to optimize pain management strategies for this specific patient population. The goal is to improve patient experiences and reduce healthcare costs associated with inadequate pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing primary Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy.
Not a fit: Patients with known hypersensitivity to acetaminophen, those unable to take pills, or those with chronic pain syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for bariatric surgery patients, enhancing their recovery experience.
How similar studies have performed: No previous studies have evaluated the effectiveness of tablet versus liquid acetaminophen in this specific patient population, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
New Brunswick, New Jersey
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Daniel T Abazia, PharmD, BCPS, CPPS — Rutgers University - Ernest Mario School of Pharmacy
- Study coordinator: Daniel T Abazia, PharmD
- Email: dabazia@pharmacy.rutgers.edu
- Phone: 773-633-5215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.