A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
181
see arm/group description
see arm/group description
Virginia Mason Medical Center
Seattle, Washington, United States
24 Hour Opioid Consumption
Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses
Time frame: 24 hours
Length of Time Under General Anesthesia
Time from induction to emergence of anesthesia
Time frame: 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.
Time frame: 24 hours
Length of Time to Recover From General Anesthesia
Time from arrival to PACU to "ready for PACU discharge"
Time frame: 1-3 hours
Length of Hospital Stay
Time from PACU arrival to discharge date and time in days
Time frame: 1-5 days
Overall Patient Satisfaction With Analgesia: Yes or no
Number of Participants With Overall Patient Satisfaction With Analgesia
Time frame: 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
Time frame: 30 days
Percentage of Patients Treated for General Anesthetic Adverse Effects
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Episodes of severe bradycardia or treated hypotension intraoperatively
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
Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery
Time frame: 3 months