Effect of Opioid Shortage on Drug Selection

April 15, 2020 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1668

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Fentanyl usage
Time Frame: September 2016 to August 2017
Monthly average amount administered per case per kg
September 2016 to August 2017
Total Fentanyl usage
Time Frame: September 2017 to May 2018
Monthly average amount administered per case per kg
September 2017 to May 2018
Total Fentanyl usage
Time Frame: June 2018 to May 2019
Monthly average amount administered per case per kg
June 2018 to May 2019

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nonopioid analgesia usage
Time Frame: September 2016 to August 2017
Monthly average amount administered per case per kg
September 2016 to August 2017
Nonopioid analgesia usage
Time Frame: September 2017 to May 2018
Monthly average amount administered per case per kg
September 2017 to May 2018
Nonopioid analgesia usage
Time Frame: June 2018 to May 2019
Monthly average amount administered per case per kg
June 2018 to May 2019
Number of CPR incidents
Time Frame: September 2016 to August 2017
post-operative complication
September 2016 to August 2017
Number of CPR incidents
Time Frame: September 2017 to May 2018
post-operative complication
September 2017 to May 2018
Number of CPR incidents
Time Frame: June 2018 to May 2019
post-operative complication
June 2018 to May 2019
Number of reintubation incidents
Time Frame: September 2016 to August 2017
post-operative complication
September 2016 to August 2017
Number of reintubation incidents
Time Frame: September 2017 to May 2018
post-operative complication
September 2017 to May 2018
Number of reintubation incidents
Time Frame: June 2018 to May 2019
post-operative complication
June 2018 to May 2019
Number of incidents requiring administration of emergency drugs
Time Frame: September 2016 to August 2017
post-operative complication
September 2016 to August 2017
Number of incidents requiring administration of emergency drugs
Time Frame: September 2016 to May 2018
post-operative complication
September 2016 to May 2018
Number of incidents requiring administration of emergency drugs
Time Frame: June 2018 to May 2019
post-operative complication
June 2018 to May 2019
Length of hospital stay
Time Frame: September 2016 to August 2017
September 2016 to August 2017
Length of hospital stay
Time Frame: September 2016 to May 2018
September 2016 to May 2018
Length of hospital stay
Time Frame: June 2018 to May 2019
June 2018 to May 2019

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: September 2016 to August 2017
Pain scores range from 0 to 10 with higher score denoting more pain
September 2016 to August 2017
Postoperative Pain Scores
Time Frame: September 2017 to May 2018
Pain scores range from 0 to 10 with higher score denoting more pain
September 2017 to May 2018
Postoperative Pain Scores
Time Frame: June 2018 to May 2019
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)
Time Frame: September 2016 to August 2017
September 2016 to August 2017
Time Spent in Post-anesthesia Care Unit (PACU)
Time Frame: September 2017 to May 2018
September 2017 to May 2018
Time Spent in Post-anesthesia Care Unit (PACU)
Time Frame: June 2018 to May 2019
June 2018 to May 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Miller, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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