A Phase 4 interventional study of Sprix in Post Operative Pain Control, Narcotic Use and Pelvic Organ Prolapse, sponsored by University of Louisville. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-29.
Sponsored by University of Louisville · Phase 4, Interventional, and Treatment
The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that be may prescribed after acute injury, for chronic conditions and following surgery the healthcare industry as a whole continues to search for alternative medications that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition. To that end this study has the following aims:
To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:
Hypothesis:
Primary:
Secondary:
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Exclusion Criteria:
To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed a "standard" postoperative regimen of Acetaminophen 650 mg PO q 6-8 hours + Ibuprofen 600 mg PO q 6-8 hours + rescue narcotics (Oxycodone 5-10 mg PO q 4-6 hours or if allergic to Oxycodone, Norco 5-10mg/325mg PO q 4-6 hours) for breakthrough pain
To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed regimen of Sprix 30.5mg Intranasal q 6-8 hour up to 4 times daily + Acetaminophen 650 mg PO q 6- 8 hours + rescue narcotics (as above) for breakthrough pain during the day of surgery and the following 4 postoperative days.
Drug: Sprix
Intranasal Ketorolac - used as directed for an appropriate, previously established indication
Also known as: Intranasal Ketorolac
Morphine mEqs
The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents
Time frame: As measured from the day of surgery to 4 days post operative
Patient Satisfaction
Evaluate patient satisfaction using the validated QoR 40 (Quality of Recovery) Scale - wherein a minimum score of 40 indicates that a patient perceives there recovery to be very poor and a maximum score of 200 indicates that the patient perceives that the quality of their recovery is excellent
Time frame: Day of surgery to 4 days postoperative
Patient's perception of current pain
The patient's pain will be subjectively scaled on a 0 (indicating no pain) to 10 (indicating maximum/severe pain) scale. The patient will be asked to scale their pain preoperatively, on postoperative day #1 and on Postoperative day #4
Time frame: Day of surgery to 4 days postoperatively
Plan to share: No
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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