Opioid Use, UnspecifiedPhase 3NCT04081545

Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery

A Phase 3 study testing Opioid Anesthetics and Non Opioid Analgesics in people with Opioid Use, Unspecified and Bariatric Surgery Candidate, run by Christine Oryhan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Opioid Use, Unspecified, Bariatric Surgery Candidate, Anesthesia
What is being tested?: Opioid Anesthetics and Non Opioid Analgesics
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 181 participants
Where: 1 siteUnited States
Study dates: 24 Dec 2019to 30 Jun 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent

Who cannot join

Any opioid use within 4 weeks prior to surgery
Chronic antiemetic use
Conversion of laparoscopic to open surgery
Patients unable to provide post-operative pain scores
Pregnant or lactating patients
Patients under 18 years of age
Refusal or inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Mason Medical Center
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: The Effect of an Opioid-free Anesthetic on Post-operative Opioid Consumption After Laparoscopic Bariatric Surgery: a Prospective, Single-blinded, Randomized Controlled Trial

A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.

Read the detailed description

This is a prospective, single-center, single-blinded, randomized controlled trial comparing the effect of an opioid-free general anesthetic versus a traditional anesthetic with a restricted quantity of opioid on postoperative opioid consumption following laparoscopic bariatric surgery. The study population will be composed of 196 subjects undergoing laparoscopic bariatric surgery at Virginia Mason Medical center randomized into two groups. The control group will receive a traditional opioid restrictive general anesthetic. The study group will receive an opioid-free anesthetic technique.

Conditions: Opioid Use, Unspecified, Bariatric Surgery Candidate, Anesthesia
Being tested: Opioid Anesthetics, Non Opioid Analgesics
Keywords: Opioid Free Anesthesia, Bariatric Surgery, Non-Opioid Anesthesia, Ketamine, Dexmedetomidine, Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opioid AnestheticsDrug
Also called Opioid-based regimen
see arm/group description
Non Opioid AnalgesicsDrug
Also called Opioid-free regimen
see arm/group description

Study groups in NCT04081545
Study group	Role	What they receive
Control Goup A- Opioid-based regimen	Active comparator	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 Receives: Drug: Opioid Anesthetics
Experimental Group B- Opioid-free regimen	Experimental	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 Receives: Drug: Non Opioid Analgesics

What is being measured

The primary outcome is the main question the study is designed to answer.

24 Hour Opioid Consumption
Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses
Measured: 24 hours

Secondary outcomes (8)

Length of Time Under General Anesthesia
Time from induction to emergence of anesthesia
Measured: 1-5 hours
Percentage of Patients With Opioid-related Adverse Effects
Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome.
Measured: 24 hours
Length of Time to Recover From General Anesthesia
Time from arrival to PACU to "ready for PACU discharge"
Measured: 1-3 hours
Length of Hospital Stay
Time from PACU arrival to discharge date and time in days
Measured: 1-5 days
Overall Patient Satisfaction With Analgesia: Yes or no
Number of Participants With Overall Patient Satisfaction With Analgesia
Measured: 24 hours
Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days
Number of participates with opioid prescription refills since surgery within 30 day after surgery
Measured: 30 days
Percentage of Patients Treated for General Anesthetic Adverse Effects
Episodes of severe bradycardia or treated hypotension intraoperatively
Measured: Intraoperative, between time entering OR and PACU arrival time
Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery
Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Dec 201930 Jun 2023

First posted9 Sep 2019
Study start24 Dec 2019
Primary completion29 Mar 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid Use, UnspecifiedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: The investigators plan to enroll 196 subjects at Virginia Mason Medical Center that are undergoing laparoscopic bariatric surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm, with a computer generated arm assignment. Subjects will be blinded to the assigned arm. Group A will receive a traditional opioid restrictive general anesthetic and group B will receive an opioid-free anesthetic technique.
Masking: Single blind
Who is masked: Participant
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04081545
Sponsor's protocol ID: CRP19060
Status last verified: Oct 2024
First submitted: 28 Aug 2019
Last updated: 20 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
RecruitingObservational study
Sensory Outcomes in Active Substance Users
Post Operative Pain, Opioid Use, Unspecified
Active, not recruiting
Patient Utilization of Opioid Destruction Bags in the Post-op Period
Opioid Use, Opioid Use, Unspecified
RecruitingObservational study
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Opioid-use Disorder, Opioid Use, Unspecified

All Opioid Use, Unspecified trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of an Opioid-free Anesthetic on Post-operative Opioid Consumption After Laparoscopic Bariatric Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04081545
Acronym / sponsor ID: CRP19060
Conditions: Opioid Use, Unspecified, Bariatric Surgery Candidate, Anesthesia
Keywords: Opioid Free Anesthesia, Bariatric Surgery, Non-Opioid Anesthesia, Ketamine, Dexmedetomidine, Lidocaine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: Christine OryhanUniversity, hospital or other
Collaborators: Virginia Mason Hospital/Medical Center
Study start: 24 Dec 2019 (actual)
Primary completion: 29 Mar 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 9 Sep 2019 (actual)
Results: Posted 20 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The investigators plan to enroll 196 subjects at Virginia Mason Medical Center that are undergoing laparoscopic bariatric surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm, with a computer generated arm assignment. Subjects will be blinded to the assigned arm. Group A will receive a traditional opioid restrictive general anesthetic and group B will receive an opioid-free anesthetic technique.

Arm	Type	Receives
Control Goup A- Opioid-based regimen	Active comparator	Drug: Opioid AnestheticsPreop - 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
Experimental Group B- Opioid-free regimen	Experimental	Drug: Non Opioid AnalgesicsPreop - 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent

Key exclusion criteria (7 listed)

Any opioid use within 4 weeks prior to surgery
Chronic antiemetic use
Conversion of laparoscopic to open surgery
Patients unable to provide post-operative pain scores
Pregnant or lactating patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opioid AnestheticsAlso: Opioid-based regimensee arm/group description	Drug	Control Goup A- Opioid-based regimen
Non Opioid AnalgesicsAlso: Opioid-free regimensee arm/group description	Drug	Experimental Group B- Opioid-free regimen

Primary outcome

24 Hour Opioid Consumption
Time frame: 24 hours
Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses

8 secondary outcomes

Length of Time Under General Anesthesia
Time frame: 1-5 hours
Percentage of Patients With Opioid-related Adverse Effects
Time frame: 24 hours
Length of Time to Recover From General Anesthesia
Time frame: 1-3 hours
Length of Hospital Stay
Time frame: 1-5 days
Overall Patient Satisfaction With Analgesia: Yes or no
Time frame: 24 hours
Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days
Time frame: 30 days
Percentage of Patients Treated for General Anesthetic Adverse Effects
Time frame: Intraoperative, between time entering OR and PACU arrival time
Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery
Time frame: 3 months

Results and safety

Results posted to the registry on 20 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Goup A- Opioid-based Regimen	86	86
Experimental Group B- Opioid-free Regimen	95	95

Primary outcome: 24 Hour Opioid Consumption

Time frame: 24 hours. Mean (Standard Deviation). Unit: mg oral morphine equivalents (OMEs)

Measure	Control Goup A- Opioid-based Regimen n = 86	Experimental Group B- Opioid-free Regimen n = 95
Including PACU	51 (34)	55 (31)
Excluding PACU	27 (24)	32 (23)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Goup A- Opioid-based Regimen	0 of 86 (0%)	51 of 86 (59.3%)	0 of 86
Experimental Group B- Opioid-free Regimen	0 of 95 (0%)	62 of 95 (65.3%)	0 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Opioid Use, Unspecified

Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
RecruitingObservational study
Sensory Outcomes in Active Substance Users
Post Operative Pain, Opioid Use, Unspecified
Active, not recruiting
Patient Utilization of Opioid Destruction Bags in the Post-op Period
Opioid Use, Opioid Use, Unspecified
RecruitingObservational study
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Opioid-use Disorder, Opioid Use, Unspecified

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine Oryhan, MD principal investigator

Virginia Mason Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Opioid Anesthetics and Non Opioid Analgesics in people with Opioid Use, Unspecified and Bariatric Surgery Candidate, run by Christine Oryhan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24 Hour Opioid Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04081545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.