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Study never opened to enrollment. Study never IRB approved.
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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:
Patient satisfaction with the aforementioned methods
Evaluate and compare pain scores via validated questionnaire
Hypothesis:
Primary:
1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following minimally invasive female pelvic surgery.
Secondary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | 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 | |
| Sprix | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sprix | Drug | Intranasal Ketorolac - used as directed for an appropriate, previously established indication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine mEqs | The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents | As measured from the day of surgery to 4 days post operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day of surgery to 4 days postoperative |
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Inclusion Criteria:
Exclusion Criteria:
Female patients - all patients in the study are those that will undergo/have undergone female pelvic surgery (Urogynecology)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | 40203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20557145 | Background | Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. | |
| 25169467 | Background | Pergolizzi JV Jr, Taylor R Jr, Raffa RB. Intranasal ketorolac as part of a multimodal approach to postoperative pain. Pain Pract. 2015 Apr;15(4):378-88. doi: 10.1111/papr.12239. Epub 2014 Aug 28. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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This is a multi-center, non-blinded, randomized control trial.
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| 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 | Day of surgery to 4 days postoperatively |
| 26782787 | Background | Pollack CV Jr, Diercks DB, Thomas SH, Shapiro NI, Fanikos J, Mace SE, Rafique Z, Todd KH. Patient-reported Outcomes from A National, Prospective, Observational Study of Emergency Department Acute Pain Management With an Intranasal Nonsteroidal Anti-inflammatory Drug, Opioids, or Both. Acad Emerg Med. 2016 Mar;23(3):331-41. doi: 10.1111/acem.12902. |
| 19020154 | Background | Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |