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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04081545
• Other study ID #: CRP19060
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 24, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: June 30, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Bariatric Surgery Candidate
• Opioid Use, Unspecified

Intervention

Drug:
• Opioid Anesthetics
see arm/group description
• Non Opioid Analgesics
see arm/group description

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Christine Oryhan	Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour opioid consumption	Total amount of opioid use within the first 24 hours after surgery in morphine equivalent doses	24 hours
Secondary	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
Secondary	Length of time under general anesthesia	Time from induction to emergence of anesthesia in minutes	1-5 hours
Secondary	Percentage of patients with opioid-related adverse effects	Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression	24 hours
Secondary	Return of bowel function	Time to diet advancement to full liquid diet and time to first bowel movement	24 hours
Secondary	Length of time to recover from general anesthesia	Time from arrival to PACU to "ready for PACU discharge" in minutes	1-3 hours
Secondary	Length of hospital stay	Time from PACU arrival to discharge date and time in hours	1-5 days
Secondary	Overall patient satisfaction with analgesia: yes or no	Satisfaction with overall post-operative pain control (yes or no)	24 hours
Secondary	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
Secondary	Percentage of patients treated for general anesthetic adverse effects	Adverse effects include hypotension, bradycardia, nausea, vomiting	1-8 hours