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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

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 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

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
Oxycodone Hydrochloride
2015
Completed Phase 4
~230
Scopolamine patch
2017
Completed Early Phase 1
~90

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,958 Total Patients Enrolled
2 Trials studying Bariatric Surgery Candidates
9,597 Patients Enrolled for Bariatric Surgery Candidates
Mohamed R Ali, MD, FACSPrincipal InvestigatorProfessor of Surgery
Barbara Jachniewicz, MSN, CRNFA,Principal InvestigatorNurse Practitioner, Department of Surgery

Media Library

Multimodal Analgesia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04240626 — Phase 4
Bariatric Surgery Candidates Research Study Groups: Standard of Care, Multi-Modal
Bariatric Surgery Candidates Clinical Trial 2023: Multimodal Analgesia Highlights & Side Effects. Trial Name: NCT04240626 — Phase 4
Multimodal Analgesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04240626 — Phase 4
~4 spots leftby Dec 2024
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