Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837014
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2021-04-05
Brief Title:
Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eNARCOS
Brief Summary:
Laparoscopic gynecologic surgeries are generally very well tolerated procedures and patients are able to go home on the same day with a prescription for pain control There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery and patients are going home with anything from zero to 5 or even 20 tabs of narcotics
Aside from negative side effect of opioids like nauseavomiting dizziness constipation and possibly addiction unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community worsening an ongoing nationwide opioid crisis Although most patients report low pain level following these kinds of procedure there are no current standard prescriptions after gynecologic laparoscopy
In an effort to standardize discharge prescriptions following gynecologic laparoscopy this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery There will be 2 standardized set of discharge prescriptions to which patient will be randomized both containing multimodal medications for pain control Pain control and patients satisfaction will be measured in the first post-operative week
Aside from negative side effect of opioids like nauseavomiting dizziness constipation and possibly addiction unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community worsening an ongoing nationwide opioid crisis Although most patients report low pain level following these kinds of procedure there are no current standard prescriptions after gynecologic laparoscopy
In an effort to standardize discharge prescriptions following gynecologic laparoscopy this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery There will be 2 standardized set of discharge prescriptions to which patient will be randomized both containing multimodal medications for pain control Pain control and patients satisfaction will be measured in the first post-operative week
Detailed Description:
Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery MIGS There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed if any for MIGS These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis
This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients Given the general tolerability and low pain associated with MIGS the investigators hypothesize that elimination of narcotics from post-operative pain control in conjunction with regular use of non-narcotic analgesics will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription
Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria Patients will be randomly allocated to either intervention or control groups in a one to one fashion Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours and then as needed for one weeks duration Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone with regular non-opioid analgesic use
All patient will be contacted on day one and seven after surgery to evaluate pain scores mobility adequacy of analgesia adherence to treatment side-effects and total opioid consumption
This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients Given the general tolerability and low pain associated with MIGS the investigators hypothesize that elimination of narcotics from post-operative pain control in conjunction with regular use of non-narcotic analgesics will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription
Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria Patients will be randomly allocated to either intervention or control groups in a one to one fashion Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours and then as needed for one weeks duration Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone with regular non-opioid analgesic use
All patient will be contacted on day one and seven after surgery to evaluate pain scores mobility adequacy of analgesia adherence to treatment side-effects and total opioid consumption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None