Acetaminophen for Post-Op Pain After Bariatric Surgery

Phase 2

Recruiting

Led By Daniel T Abazia, PharmD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Medical exclusions: 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.

Surgical exclusions: Duodenal Switch (DS) surgeries, Adjustable Gastric Banding (AGB), surgical revisions, and surgical conversions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of consent until the date of hospital discharge, assessed up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how patients with morbid obesity who have undergone weight loss surgery metabolize acetaminophen (a common pain reliever). The study will compare how well the body absorbs and

Who is the study for?

This trial is for adults with morbid obesity who have undergone Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Participants should be in need of postoperative pain management and able to take oral medication. Specific details on inclusion and exclusion criteria are not provided.

What is being tested?

The study aims to compare the effectiveness of liquid versus pill forms of acetaminophen for managing post-op pain in bariatric surgery patients, considering their unique drug metabolism challenges.

What are the potential side effects?

While specific side effects are not listed, common ones associated with acetaminophen include nausea, allergic reactions, skin rash, and at high doses a risk of liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and eligible for weight loss surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a chronic pain condition or a history of opioid use.

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I have not had weight loss surgeries like DS, AGB, or any surgical revisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of consent until the date of hospital discharge, assessed up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of consent until the date of hospital discharge, assessed up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of consent until the date of hospital discharge, assessed up to 3 months for reporting.