Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
Completed
NCT Number: NCT04099030
Effect of Opioid Shortage on Drug Selection
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Total Fentanyl usage
Time frame: September 2016 to August 2017
Monthly average amount administered per case per kg
-
Total Fentanyl usage
Time frame: September 2017 to May 2018
Monthly average amount administered per case per kg
-
Total Fentanyl usage
Time frame: June 2018 to May 2019
Monthly average amount administered per case per kg
Secondary outcomes
-
Nonopioid analgesia usage
Time frame: September 2016 to August 2017
Monthly average amount administered per case per kg
-
Nonopioid analgesia usage
Time frame: September 2017 to May 2018
Monthly average amount administered per case per kg
-
Nonopioid analgesia usage
Time frame: June 2018 to May 2019
Monthly average amount administered per case per kg
-
Number of CPR incidents
Time frame: September 2016 to August 2017
post-operative complication
-
Number of CPR incidents
Time frame: September 2017 to May 2018
post-operative complication
-
Number of CPR incidents
Time frame: June 2018 to May 2019
post-operative complication
-
Number of reintubation incidents
Time frame: September 2016 to August 2017
post-operative complication
-
Number of reintubation incidents
Time frame: September 2017 to May 2018
post-operative complication
-
Number of reintubation incidents
Time frame: June 2018 to May 2019
post-operative complication
-
Number of incidents requiring administration of emergency drugs
Time frame: September 2016 to August 2017
post-operative complication
-
Number of incidents requiring administration of emergency drugs
Time frame: September 2016 to May 2018
post-operative complication
-
Number of incidents requiring administration of emergency drugs
Time frame: June 2018 to May 2019
post-operative complication
-
Length of hospital stay
Time frame: September 2016 to August 2017
-
Length of hospital stay
Time frame: September 2016 to May 2018
-
Length of hospital stay
Time frame: June 2018 to May 2019
Other outcomes
-
Postoperative Pain Scores
Time frame: September 2016 to August 2017
Pain scores range from 0 to 10 with higher score denoting more pain
-
Postoperative Pain Scores
Time frame: September 2017 to May 2018
Pain scores range from 0 to 10 with higher score denoting more pain
-
Postoperative Pain Scores
Time frame: June 2018 to May 2019
Pain scores range from 0 to 10 with higher score denoting more pain
-
Time Spent in Post-anesthesia Care Unit (PACU)
Time frame: September 2016 to August 2017
-
Time Spent in Post-anesthesia Care Unit (PACU)
Time frame: September 2017 to May 2018
-
Time Spent in Post-anesthesia Care Unit (PACU)
Time frame: June 2018 to May 2019
Sponsors and collaborators
Lead sponsor
Wake Forest University Health Sciences
Other
Registry information
Official study title
The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
Important dates
- Study start
- 2019
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Sep 23, 2019
- Registry last updated
- Apr 16, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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