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Effect of Opioid Shortage on Drug Selection

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Opioid Use, Unspecified

Study type

Observational

Funder types

Other

Identifiers

NCT04099030
IRB00057062

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,668 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,668 participants in 2 patient groups

Opioid shortage
Description:
Patients undergoing laparoscopic cholecystectomy during time of Fentanyl drug shortage
Normal Opioid supply (no shortage)
Description:
Patients undergoing laparoscopic cholecystectomy during time of normal Fentanyl drug supply

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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