Effect of Opioid Shortage on Drug Selection

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy

Conditions
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Opioid Use, Unspecified

Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Regional Anesthetic ASA 5 and 6

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Opioid shortage<br>Patients undergoing laparoscopic cholecystectomy during time of Fentanyl drug shortage | |
| Normal Opioid supply (no shortage)<br>Patients undergoing laparoscopic cholecystectomy during time of normal Fentanyl drug supply | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Fentanyl usage | Monthly average amount administered per case per kg | September 2016 to August 2017 | 
| Total Fentanyl usage | Monthly average amount administered per case per kg | September 2017 to May 2018 | 
| Total Fentanyl usage | Monthly average amount administered per case per kg | June 2018 to May 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nonopioid analgesia usage | Monthly average amount administered per case per kg | September 2016 to August 2017 | 
| Nonopioid analgesia usage | Monthly average amount administered per case per kg | September 2017 to May 2018 | 
| Nonopioid analgesia usage | Monthly average amount administered per case per kg | June 2018 to May 2019 | 
| Number of CPR incidents | post-operative complication | September 2016 to August 2017 | 
| Number of CPR incidents | post-operative complication | September 2017 to May 2018 | 
| Number of CPR incidents | post-operative complication | June 2018 to May 2019 | 
| Number of reintubation incidents | post-operative complication | September 2016 to August 2017 | 
| Number of reintubation incidents | post-operative complication | September 2017 to May 2018 | 
| Number of reintubation incidents | post-operative complication | June 2018 to May 2019 | 
| Number of incidents requiring administration of emergency drugs | post-operative complication | September 2016 to August 2017 | 
| Number of incidents requiring administration of emergency drugs | post-operative complication | September 2016 to May 2018 | 
| Number of incidents requiring administration of emergency drugs | post-operative complication | June 2018 to May 2019 | 
| Length of hospital stay |  | September 2016 to August 2017 | 
| Length of hospital stay |  | September 2016 to May 2018 | 
| Length of hospital stay |  | June 2018 to May 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug shortage