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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bariatric Surgery Candidate; Anesthesia; Opioid Use, Unspecified
• Intervention / Treatment: Drug: Opioid Anesthetics; Drug: Non Opioid Analgesics

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christine L Oryhan, MD; Phone Number: 206-223-6980; Email: christine.oryhan@virginiamason.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Goup A- Opioid-based regimen; 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; see arm/group description; Other Names: Opioid-based regimen
Experimental: Experimental Group B- Opioid-free regimen; 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; see arm/group description; 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

Collaborators and Investigators

• Sponsor: Christine Oryhan
• Collaborators: Virginia Mason Hospital/Medical Center
• Investigators: Principal Investigator: Christine Oryhan, MD, Virginia Mason Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Actual): March 29, 2023
• Study Completion (Estimated): June 30, 2023

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Ketamine; Dexmedetomidine; Bariatric Surgery; Lidocaine; Opioid Free Anesthesia; Non-Opioid Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid; Analgesics; Analgesics, Non-Narcotic
• Other Study ID Numbers: CRP19060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No