Effect of Opioid Shortage on Drug Selection

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use, Unspecified

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.

• Study Type: Observational
• Enrollment (Actual): 1668

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nonopioid analgesia usage	Monthly average amount administered per case per kg	September 2016 to August 2017
Nonopioid analgesia usage	Monthly average amount administered per case per kg	September 2017 to May 2018
Nonopioid analgesia usage	Monthly average amount administered per case per kg	June 2018 to May 2019
Number of CPR incidents	post-operative complication	September 2016 to August 2017
Number of CPR incidents	post-operative complication	September 2017 to May 2018
Number of CPR incidents	post-operative complication	June 2018 to May 2019
Number of reintubation incidents	post-operative complication	September 2016 to August 2017
Number of reintubation incidents	post-operative complication	September 2017 to May 2018
Number of reintubation incidents	post-operative complication	June 2018 to May 2019
Number of incidents requiring administration of emergency drugs	post-operative complication	September 2016 to August 2017
Number of incidents requiring administration of emergency drugs	post-operative complication	September 2016 to May 2018
Number of incidents requiring administration of emergency drugs	post-operative complication	June 2018 to May 2019
Length of hospital stay		September 2016 to August 2017
Length of hospital stay		September 2016 to May 2018
Length of hospital stay		June 2018 to May 2019

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Scores	Pain scores range from 0 to 10 with higher score denoting more pain	September 2016 to August 2017
Postoperative Pain Scores	Pain scores range from 0 to 10 with higher score denoting more pain	September 2017 to May 2018
Postoperative Pain Scores	Pain scores range from 0 to 10 with higher score denoting more pain	June 2018 to May 2019
Time Spent in Post-anesthesia Care Unit (PACU)		September 2016 to August 2017
Time Spent in Post-anesthesia Care Unit (PACU)		September 2017 to May 2018
Time Spent in Post-anesthesia Care Unit (PACU)		June 2018 to May 2019

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Scott Miller, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: drug shortage
• Other Study ID Numbers: IRB00057062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No