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Opioid Analgesic
Pain Management Strategies for Postoperative Pain
Phase 4
Waitlist Available
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery scheduled electively from the BUMCP Bariatric Clinic
BMI>35kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative until patient discharge or up to 90 days, whichever comes first
Awards & highlights
Study Summary
This trial is investigating the role of different types of pain medication in patients recovering from bariatric surgery, in order to find the most effective way to manage pain for this population.
Who is the study for?
This trial is for adults over 18 who are scheduled for elective Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery with a BMI over 35. It's not for those pregnant, on chronic pain narcotics, having re-operative bariatric surgery, unable to walk, with significant liver disease, insulin-treated diabetes, advanced kidney disease, pulmonary hypertension or heart failure.Check my eligibility
What is being tested?
The study compares four pain management strategies after bariatric surgery: narcotic and non-narcotic regimens both with and without TAP block (a local anesthesia technique). Participants will report their pain and nausea levels regularly during a 90-day post-surgery period.See study design
What are the potential side effects?
Possible side effects include typical reactions to narcotics like drowsiness or constipation and potential issues related to the TAP block such as localized discomfort. Non-narcotic side effects might involve less severe symptoms but vary based on the specific medication used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for weight loss surgery at the BUMCP Bariatric Clinic.
Select...
My BMI is over 35.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative until patient discharge or up to 90 days, whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative until patient discharge or up to 90 days, whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
postoperative pain
Secondary outcome measures
200 foot ambulation
Hospital length of stay
Postoperative nausea
+1 moreTrial Design
4Treatment groups
Active Control
Group I: narcotic regimen with TAP blockActive Control1 Intervention
Patient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively
Group II: non-narcotic regimen with no TAP blockActive Control1 Intervention
Patient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively
Group III: non-narcotic regimen with TAP blockActive Control1 Intervention
Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively
Group IV: narcotic regimen with no TAP blockActive Control1 Intervention
Patient will not receive TAP block and will be administered the Narcotic Pain Regimen post-operatively
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,027 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to have or have had a second bariatric surgery.I am on pain medication since my first visit or before surgery.I have been diagnosed with Congestive Heart Failure.I have been diagnosed with Pulmonary Hypertension.I am scheduled for weight loss surgery at the BUMCP Bariatric Clinic.I use insulin to manage my diabetes.I have a serious liver condition.My BMI is over 35.I am 18 years old or older.I cannot walk 200 feet on my own.My kidney function is severely reduced.I am allergic to narcotics, steroids, or certain medications.I was admitted to the ICU following surgery.
Research Study Groups:
This trial has the following groups:- Group 1: narcotic regimen with TAP block
- Group 2: non-narcotic regimen with no TAP block
- Group 3: non-narcotic regimen with TAP block
- Group 4: narcotic regimen with no TAP block
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
To what extent is the population being examined by this research endeavor?
"Affirmative. The clinicaltrials.gov page for this medical trial, that was first published on February 18th 2022, shows evidence of ongoing recruitment efforts. This initiative needs to recruit a total of 244 participants from 1 site."
Answered by AI
Is there a risk associated with administering narcotics in combination with the TAP block procedure?
"Due to this being a Phase 4 trial, which indicates the treatment has been approved for use, our team at Power rated its safety as 3 on a scale from 1-3."
Answered by AI
Is the recruitment phase of this clinical trial currently taking place?
"Affirmative. Clinicaltrials.gov records indicate that this clinical trial, launched on February 18th 2022, is actively recruiting applicants. This medical research requires the enrollment of 244 individuals from a single location."
Answered by AI
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