Phase 3 N=181 Randomized Single-blind Other

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

Opioid Use, Unspecified · Bariatric Surgery Candidate · Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT04081545 ↗

Enrolled (actual)

181

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: 24 Hour Opioid Consumption — 51; 55; 27; 32 mg oral morphine equivalents (OMEs)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Opioid Anesthetics (Drug); Non Opioid Analgesics (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Christine Oryhan
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY 24 Hour Opioid Consumption	51; 55; 27; 32	—
SECONDARY Length of Time Under General Anesthesia	3.47; 3.32	—
SECONDARY Percentage of Patients With Opioid-related Adverse Effects	19; 16; 2; 4; 21; 29	—
SECONDARY Length of Time to Recover From General Anesthesia	1.33; 1.41	—
SECONDARY Length of Hospital Stay	1.45; 1.58	—
SECONDARY Overall Patient Satisfaction With Analgesia: Yes or no	73; 72	—
SECONDARY Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days	9; 10	—
SECONDARY Percentage of Patients Treated for General Anesthetic Adverse Effects	10; 17; 41; 67; 28; 54	—
SECONDARY Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery	8; 4	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04081545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.