Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532708
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices or with the use of a calculator ie the Opioid Calculator published by the University of Michigan wwwopioidcalculatororg with the intent of decreasing the number of pills
Detailed Description:
The intent of this study is to validate the use of the Opioid Calculator published at University of Michigan wwwopioidcalculatororg which takes several variables into account including age risk factors history of depression alcohol abuse others to determine in a more scientific way the number of pills sufficient to prescribe The sample size was determined by the number of routine post-op laparoscopic patients seen in our practice The estimated necessary sample size is 6 participants per group 12 total Patients will be randomized using 3 block groups of size 4 each Patients will be approached at in clinic at the time they are consenting to laparoscopic hysterectomy and will be counseled about postoperative pain medication management Randomization to either standard practice or calculator will be performed using computer-generated permuted blocks of 4 participants Sealed randomization envelopes will be opened for each subject on the day of surgery after anesthesia is initiated The study will be singled-blinded to the participant Patients will be contacted on day 2 and day 7 to inquire where they are on the Visual Analog Scale VAS and how many pills they have taken Two weeks after surgery patients will be seen in office for VAS and requested to bring unused pills for accounting purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None