Effect of Opioid Shortage on Drug Selection

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04099030

Enrollment

1668

Registered

2019-09-23

Start date

2019-04-05

Completion date

2019-12-13

Last updated

2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Unspecified

Keywords

drug shortage

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Total Fentanyl usage	September 2016 to August 2017	Monthly average amount administered per case per kg

Secondary

Measure	Time frame	Description
Nonopioid analgesia usage	September 2016 to August 2017	Monthly average amount administered per case per kg
Number of CPR incidents	September 2016 to August 2017	post-operative complication
Number of reintubation incidents	September 2016 to August 2017	post-operative complication
Number of incidents requiring administration of emergency drugs	September 2016 to August 2017	post-operative complication
Length of hospital stay	September 2016 to August 2017	—

Other

Measure	Time frame	Description
Postoperative Pain Scores	September 2016 to August 2017	Pain scores range from 0 to 10 with higher score denoting more pain
Time Spent in Post-anesthesia Care Unit (PACU)	September 2016 to August 2017	—

Countries

United States

Outcome results