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Non-Narcotic Pain Medication for Post-Surgery Pain in Bariatric Patients

Phase 4

Recruiting

Led By Mohamed R Ali, MD, FACS

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

American Society of Anesthesiology (ASA) score of 3 or less

Women with a BMI >=30

Must not have

ASA score of 4 or higher

Do not meet the NIH Standards for weight loss surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days and 14 days post surgery

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study whether non-narcotic pain medications are effective in controlling pain for patients undergoing Bariatric Surgery at UC Davis Medical Center.

Who is the study for?

This trial is for women aged 35-65 with obesity (BMI >=30) who are undergoing bariatric surgery at UC Davis Medical Center and have an ASA score of ≤3. Candidates must not have had previous abdominal surgeries, be planning additional procedures, or suffer from chronic pain conditions like arthritis or fibromyalgia.

What is being tested?

The study compares standard pain control medications to a regimen of non-narcotic drugs in post-bariatric surgery patients. One group will receive typical analgesics while the other will get alternative options with rescue meds available if necessary.

What are the potential side effects?

Possible side effects include drowsiness, nausea, constipation, dry mouth from Ativan; itching or sweating from Dilaudid; liver issues from Tylenol; dizziness and dry mouth from Neurontin; sedation and confusion from Flexeril; as well as potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My health is stable enough for surgery according to the ASA score.

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My BMI is 30 or higher.

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I am between 35 and 65 years old.

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I have never had surgery on my abdomen or upper digestive tract.

Exclusion Criteria

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

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My health is severely limited by my illness.

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I do not qualify for weight loss surgery according to NIH standards.

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I am a man.

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I am having additional surgeries like gallbladder removal during my main surgery.

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I need daily oral pain medication for another condition.

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I am either under 35 or over 65 years old.

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I have not had weight loss surgery.

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I have had surgery on my abdomen, including hernia repair or stomach surgery.

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I am considering or planning gender modification.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days and 14 days post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days and 14 days post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days and 14 days post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change In Post Operative Pain Intensity

Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multi-ModalExperimental Treatment10 Interventions

Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.

Group II: Standard of CareActive Control8 Interventions

The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neurontin

2009

Completed Phase 4

~80

Marcaine Injectable Product

2018

N/A

~50