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

Study Overview
=================
Brief Summary
-----------------
A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.

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.

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

Conditions
-----------------
Opioid Use, Unspecified, Bariatric Surgery Candidate, Anesthesia

Intervention / Treatment
-----------------
* Drug: Opioid Anesthetics
* Drug: Non Opioid Analgesics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Goup A- Opioid-based regimen<br>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 | Drug: Opioid Anesthetics<br>* see arm/group description<br>* Other names: Opioid-based regimen;|
| Experimental: Experimental Group B- Opioid-free regimen<br>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 | Drug: Non Opioid Analgesics<br>* see arm/group description<br>* Other names: Opioid-free regimen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour opioid consumption | Total amount of opioid use within the first 24 hours after surgery in morphine equivalent doses | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessment with numeric rating scale (NRS) | The Numeric Rating Scale (NRS) for evaluating level of pain. The rating is verbal, and the subject is asked to estimate current pain intensity on an 11-point scale, where 0 indicates no pain at all and 10 the worst imaginable pain. This will be performed in the PACU, within first 24 hours after surgery, at 30 day follow-up phone call and at 3 month follow-up visit | 3 months | 
| Length of time under general anesthesia | Time from induction to emergence of anesthesia in minutes | 1-5 hours | 
| Percentage of patients with opioid-related adverse effects | Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression | 24 hours | 
| Return of bowel function | Time to diet advancement to full liquid diet and time to first bowel movement | 24 hours | 
| Length of time to recover from general anesthesia | Time from arrival to PACU to ready for PACU discharge in minutes | 1-3 hours | 
| Length of hospital stay | Time from PACU arrival to discharge date and time in hours | 1-5 days | 
| Overall patient satisfaction with analgesia: yes or no | Satisfaction with overall post-operative pain control (yes or no) | 24 hours | 
| Incidence of post-surgical opioid prescription refills | Number of opioid prescription refills since surgery to be assessed at 30 day follow-up phone call and 3 month follow-up visit | 3 months | 
| Percentage of patients treated for general anesthetic adverse effects | Adverse effects include hypotension, bradycardia, nausea, vomiting | 1-8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid Free Anesthesia, Bariatric Surgery, Non-Opioid Anesthesia, Ketamine, Dexmedetomidine, Lidocaine