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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS
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| Name | Affiliation | Role |
|---|---|---|
| Scott Miller, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30367645 | Background | 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. |
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| 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 |
| 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 |