Clinical trial NCT04099030: Effect of Opioid Shortage on Drug Selection
Official title: The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use, Unspecified
Keywords: drug shortage
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 1668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Fentanyl usage
timeFrame: September 2016 to August 2017
measure: Total Fentanyl usage
timeFrame: September 2017 to May 2018
measure: Total Fentanyl usage
timeFrame: June 2018 to May 2019
Secondary outcomes:
measure: Nonopioid analgesia usage
timeFrame: September 2016 to August 2017
measure: Nonopioid analgesia usage
timeFrame: September 2017 to May 2018
measure: Nonopioid analgesia usage
timeFrame: June 2018 to May 2019
measure: Number of CPR incidents
timeFrame: September 2016 to August 2017
measure: Number of CPR incidents
timeFrame: September 2017 to May 2018
measure: Number of CPR incidents
timeFrame: June 2018 to May 2019
measure: Number of reintubation incidents
timeFrame: September 2016 to August 2017
measure: Number of reintubation incidents
timeFrame: September 2017 to May 2018
measure: Number of reintubation incidents
timeFrame: June 2018 to May 2019
measure: Number of incidents requiring administration of emergency drugs
timeFrame: September 2016 to August 2017
measure: Number of incidents requiring administration of emergency drugs
timeFrame: September 2016 to May 2018
measure: Number of incidents requiring administration of emergency drugs
timeFrame: June 2018 to May 2019
measure: Length of hospital stay
timeFrame: September 2016 to August 2017
measure: Length of hospital stay
timeFrame: September 2016 to May 2018
measure: Length of hospital stay
timeFrame: June 2018 to May 2019
Other outcomes:
measure: Postoperative Pain Scores
timeFrame: September 2016 to August 2017
measure: Postoperative Pain Scores
timeFrame: September 2017 to May 2018
measure: Postoperative Pain Scores
timeFrame: June 2018 to May 2019
measure: Time Spent in Post-anesthesia Care Unit (PACU)
timeFrame: September 2016 to August 2017
measure: Time Spent in Post-anesthesia Care Unit (PACU)
timeFrame: September 2017 to May 2018
measure: Time Spent in Post-anesthesia Care Unit (PACU)
timeFrame: June 2018 to May 2019
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klaus DA, de Bettignies AM, Seemann R, Krenn CG, Roth GA. Impact of a remifentanil supply shortage on mechanical ventilation in a tertiary care hospital: a retrospective comparison. Crit Care. 2018 Oct 26;22(1):267. doi: 10.1186/s13054-018-2198-3.