Effect of Opioid Shortage on Drug Selection
The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
1 other identifier
observational
1,668
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2019
CompletedFirst Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedApril 16, 2020
September 1, 2019
8 months
September 19, 2019
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (15)
Nonopioid analgesia usage
September 2016 to August 2017
Nonopioid analgesia usage
September 2017 to May 2018
Nonopioid analgesia usage
June 2018 to May 2019
Number of CPR incidents
September 2016 to August 2017
Number of CPR incidents
September 2017 to May 2018
- +10 more secondary outcomes
Other Outcomes (6)
Postoperative Pain Scores
September 2016 to August 2017
Postoperative Pain Scores
September 2017 to May 2018
Postoperative Pain Scores
June 2018 to May 2019
- +3 more other outcomes
Study Arms (2)
Opioid shortage
Patients undergoing laparoscopic cholecystectomy during time of Fentanyl drug shortage
Normal Opioid supply (no shortage)
Patients undergoing laparoscopic cholecystectomy during time of normal Fentanyl drug supply
Eligibility Criteria
Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS
You may qualify if:
- 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
You may not qualify if:
- Regional Anesthetic
- ASA 5 and 6
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
Related Publications (1)
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.
PMID: 30367645BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Miller, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 23, 2019
Study Start
April 5, 2019
Primary Completion
December 13, 2019
Study Completion
December 13, 2019
Last Updated
April 16, 2020
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share