Opioid Use, UnspecifiedNCT04099030
Effect of Opioid Shortage on Drug Selection
An observational study of Opioid Use, Unspecified, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Unspecified
- How many people
- 1,668 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 13 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS
Who may be able to join
- 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
Who cannot join
- Regional Anesthetic
- ASA 5 and 6
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use, Unspecified
- Keywords
- drug shortage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total Fentanyl usage
Monthly average amount administered per case per kg
Measured: September 2016 to August 2017
Total Fentanyl usage
Monthly average amount administered per case per kg
Measured: September 2017 to May 2018
Total Fentanyl usage
Monthly average amount administered per case per kg
Measured: June 2018 to May 2019
Secondary outcomes (15)
Nonopioid analgesia usage
Monthly average amount administered per case per kg
Measured: September 2016 to August 2017
Nonopioid analgesia usage
Monthly average amount administered per case per kg
Measured: September 2017 to May 2018
Nonopioid analgesia usage
Monthly average amount administered per case per kg
Measured: June 2018 to May 2019
Number of CPR incidents
post-operative complication
Measured: September 2016 to August 2017
Number of CPR incidents
post-operative complication
Measured: September 2017 to May 2018
Number of CPR incidents
post-operative complication
Measured: June 2018 to May 2019
Number of reintubation incidents
post-operative complication
Measured: September 2016 to August 2017
Number of reintubation incidents
post-operative complication
Measured: September 2017 to May 2018
Number of reintubation incidents
post-operative complication
Measured: June 2018 to May 2019
Number of incidents requiring administration of emergency drugs
post-operative complication
Measured: September 2016 to August 2017
Number of incidents requiring administration of emergency drugs
post-operative complication
Measured: September 2016 to May 2018
Number of incidents requiring administration of emergency drugs
post-operative complication
Measured: June 2018 to May 2019
Length of hospital stay
Measured: September 2016 to August 2017
Length of hospital stay
Measured: September 2016 to May 2018
Length of hospital stay
Measured: June 2018 to May 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start5 Apr 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Miller, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099030
- Sponsor's protocol ID
- IRB00057062
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30367645
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04099030
- Acronym / sponsor ID
- IRB00057062
- Conditions
- Opioid Use, Unspecified
- Keywords
- drug shortage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,668 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Regional Anesthetic
- ASA 5 and 6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
15 secondary outcomes
Nonopioid analgesia usage
Time frame: September 2016 to August 2017
Nonopioid analgesia usage
Time frame: September 2017 to May 2018
Nonopioid analgesia usage
Time frame: June 2018 to May 2019
Number of CPR incidents
Time frame: September 2016 to August 2017
Number of CPR incidents
Time frame: September 2017 to May 2018
Number of CPR incidents
Time frame: June 2018 to May 2019
Number of reintubation incidents
Time frame: September 2016 to August 2017
Number of reintubation incidents
Time frame: September 2017 to May 2018
Number of reintubation incidents
Time frame: June 2018 to May 2019
Number of incidents requiring administration of emergency drugs
Time frame: September 2016 to August 2017
Number of incidents requiring administration of emergency drugs
Time frame: September 2016 to May 2018
Number of incidents requiring administration of emergency drugs
Time frame: June 2018 to May 2019
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Background: PubMed 30367645Klaus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Miller, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use, Unspecified, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fentanyl usage (time frame: September 2016 to August 2017). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.