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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days and 14 days post surgery
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
911 Previous Clinical Trials
4,709,523 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My health is stable enough for surgery according to the ASA score.My health is severely limited by my illness.I do not qualify for weight loss surgery according to NIH standards.I am a man.I have arthritis, fibromyalgia, or chronic pain syndrome.I am having additional surgeries like gallbladder removal during my main surgery.You are allergic to gabapentin.I need daily oral pain medication for another condition.I am either under 35 or over 65 years old.My BMI is 30 or higher.I have not had weight loss surgery.I have had surgery on my abdomen, including hernia repair or stomach surgery.I am between 35 and 65 years old.I have never had surgery on my abdomen or upper digestive tract.I am considering or planning gender modification.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Multi-Modal
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Dilaudid Injectable Product been given the green light by the FDA?
"Dilaudid Injectable Product has been approved, so our team assigned it a safety score of 3."
Answered by AI
Would I be eligible to participate in this trial?
"In order to be admitted into this clinical trial, applicants must possess obesity and morbidity along with being within the age bracket of 35-65. Presently, a total of 60 individuals are eligible for participation."
Answered by AI
Could you elucidate on what research has already been conducted pertaining to Dilaudid Injectable Product?
"Currently, 265 clinical trials are actively studying the effects of Dilaudid Injectable Product. Of those in progress 60 have reached Phase 3. Boston, Massachusetts is home to many of these studies, but there are 1864 other locations hosting this medical research around the world."
Answered by AI
For what ailment is Dilaudid Injectable Product often prescribed?
"Synovitis is typically managed with Dilaudid Injectable Product, which can also be employed to tackle ailments such as whiplash syndrome, anxiety, and ophthalmia sympathetic."
Answered by AI
Are individuals younger than 20 years of age eligible for this experiment?
"The minimum age requirement for this trial is 35 years old and the maximum permissible age of participants is 65."
Answered by AI
Is recruitment for this experiment still open?
"According to the clinicaltrials.gov database, enrollment is currently open for this study which was initially published on January 20th 2021 and underwent its most recent update at 11 March 2022."
Answered by AI
How many individuals are engaged with this trial?
"Affirmative. According to clinicaltrials.gov, this medical study is actively accepting participants since its posting on January 20th 2021 and the most recent update was done in March 11th 2022; it requires 60 individuals from a single site."
Answered by AI
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