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Non Opioid Analgesics

Non Opioid Analgesics for Bariatric Surgery Candidates

Phase 3
Waitlist Available
Led By Christine Oryhan, MD
Research Sponsored by Christine Oryhan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial looks at whether patients who have laparoscopic bariatric surgery and receive anesthesia without opioids have less post-operative pain and use fewer opioids than patients who receive anesthesia with opioids.

Eligible Conditions
  • Bariatric Surgery Candidates
  • Opioid Use Disorder
  • Anesthesia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
24 hour opioid consumption
Secondary outcome measures
Incidence of post-surgical opioid prescription refills
Length of hospital stay
Length of time to recover from general anesthesia
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group B- Opioid-free regimenExperimental Treatment1 Intervention
Preop - Multimodals unless contraindicated Induction Dexmedetomidine 1mcg/kg IV bolus over 10 minutes using IBW Lidocaine 1.5mg/kg IV bolus using IBW Propofol 2-3mg/kg IV bolus Neuromuscular blockade per Anesthesiology team discretion Ketamine 0.5mg/kg IV bolus (based on IBW) Maintenance Sevoflurane Dexmedetomidine 0.4 mcg/kg/hr IV infusion using IBW (may titrate based on patient response between 0.3-0.5mcg/kg/hr) Lidocaine 2mg/kg/hr IV infusion using IBW May use esmolol as needed to treat SBP or HR > 20% of baseline Neuromuscular blockade at the discretion of anesthesiology team Emergence Dexmedetomidine infusion turned off during laparoscopic desufflation Lidocaine infusion turned off at skin closure Neuromuscular reversal, dosed according to VM protocol Pt extubated and brought to PACU PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch
Group II: Control Goup A- Opioid-based regimenActive Control1 Intervention
Preop - Multimodals unless contraindicated Induction Fentanyl (50mcg IV) Lidocaine 1.5mg/kg IV bolus using IBW (Ideal body weight) Propofol 2-3mg/kg IV bolus Neuromuscular blockade per Anesthesiology team discretion Maintenance Sevoflurane Neuromuscular blockade at discretion of anesthesiology team May use fentanyl to treat SBP or HR > 20% of baseline Emergence Neuromuscular reversal, dosed according to Virginia Mason protocol May titrate fentanyl per anesthesiology team throughout the case. Patient extubated and brought to PACU PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Non Opioid Analgesics
2020
Completed Phase 3
~10

Find a Location

Who is running the clinical trial?

Virginia Mason Hospital/Medical CenterOTHER
20 Previous Clinical Trials
3,242 Total Patients Enrolled
Christine OryhanLead Sponsor
Christine Oryhan, MDPrincipal Investigator - Virginia Mason Medical Center
Benaroya Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Non Opioid Analgesics medication accepted by the FDA?

"This class of drugs has shown efficacy in multiple trials and has a good safety profile, so we've rated it a 3."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
Virginia Mason Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery
Christine Oryhan 2019. "Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04081545.
~35 spots leftby Apr 2025
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