Effect of Opioid Shortage on Drug Selection

Completed

• Conditions: Opioid Use, Unspecified

• Registration Number: NCT04099030
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This study will look at the effects of fentanyl shortage in laparoscopic cholecystectomy cases. The opioid shortage, specifically hydromorphone and fentanyl, caused a decrease in administration of opioid analgesia for laparoscopic cholecystectomy intraoperatively.

Detailed Description

The goal of this study is to look at the clinical impact of the drug shortage of intravenous (IV) opioids from 2016 to 2018. IV opioids are used in the hospital setting ranging from the Emergency Department to the Intensive Care Unit (ICU) to the Operating room. This study will look at the usage of IV opioids in the operating room setting and determine how practice has change in the setting of drug shortage. The study team hypothesizes that the average monthly consumption of fentanyl and hydrophone would have been decreased for laparoscopic cholecystectomy intraoperatively during the opioid shortage period as compared to before the shortage period.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-04-05
• Status Verified: 2019-09
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Primary Completion: 2019-12-13
• Study Completion: 2019-12-13
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1668

Inclusion Criteria

• All Genders
• History of laparoscopic cholecystectomy
• American Society of Anesthesiologist classification (ASA) 1-4 emergent and Non emergent
• Adult >18 years old
• Wake Forest Baptist Medical Center Main Operating rooms

Read More

Exclusion Criteria

• Regional Anesthetic
• ASA 5 and 6

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Fentanyl usage	June 2018 to May 2019	Monthly average amount administered per case per kg

Secondary Outcome Measures

Name	Time	Method
Number of CPR incidents	June 2018 to May 2019	post-operative complication
Number of reintubation incidents	June 2018 to May 2019	post-operative complication
Number of incidents requiring administration of emergency drugs	June 2018 to May 2019	post-operative complication
Nonopioid analgesia usage	June 2018 to May 2019	Monthly average amount administered per case per kg
Length of hospital stay	June 2018 to May 2019

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States