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NCT Number: NCT04081545

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

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

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Key information

Conditions

Opioid Use, Unspecified Anesthesia Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Anesthetics

Drug

see arm/group description

Other names: Opioid-based regimen

Non Opioid Analgesics

Drug

see arm/group description

Other names: Opioid-free regimen

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of Time Under General Anesthesia

    Time frame: 1-5 hours

    Time from induction to emergence of anesthesia

  2. Percentage of Patients With Opioid-related Adverse Effects

    Time frame: 24 hours

    Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome.

  3. Length of Time to Recover From General Anesthesia

    Time frame: 1-3 hours

    Time from arrival to PACU to "ready for PACU discharge"

  4. Length of Hospital Stay

    Time frame: 1-5 days

    Time from PACU arrival to discharge date and time in days

  5. Overall Patient Satisfaction With Analgesia: Yes or no

    Time frame: 24 hours

    Number of Participants With Overall Patient Satisfaction With Analgesia

  6. Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days

    Time frame: 30 days

    Number of participates with opioid prescription refills since surgery within 30 day after surgery

  7. Percentage of Patients Treated for General Anesthetic Adverse Effects

    Time frame: Intraoperative, between time entering OR and PACU arrival time

    Episodes of severe bradycardia or treated hypotension intraoperatively

  8. Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery

    Time frame: 3 months

    Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery

Sponsors and collaborators

Lead sponsor

Christine Oryhan

Other

Collaborators

  • Virginia Mason Hospital/Medical Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2019
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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