Sprix for Postoperative Pain Control Following Gynecologic Surgery

Study Overview
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Brief Summary
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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: Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol) Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol) 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: Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes maximum experience of pain Patients in the Sprix protocol will have lower numeric pain score and on POD#4 Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1 Patients in the Sprix protocol will have higher QoR-40 scores on POD#4 Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home

Official Title
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Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?

Conditions
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Pelvic Organ Prolapse, Post Operative Pain Control, Narcotic Use, Urinary Incontinence , Stress, Surgery

Intervention / Treatment
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* Drug: Sprix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years of age Weight ≥ 110lbs English Speaking and Reading All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP) surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic assisted vaginal prolapse surgery - with or without Bilateral or Unilateral Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary anti-incontinence surgery Exclusion Criteria: Patients taking opioids chronically at the time of surgery History of Coronary Artery Bypass Graft (CABG) History of peptic ulcer disease or bleeding in the stomach or intestines History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID) Uncontrolled hypertension at the time of consent and/or surgery History of renal impairment as defined by blood creatinine of 1.1 or greater at any time

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-center, non-blinded, randomized control trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>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 | |
| Experimental: Sprix<br>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<br>* Intranasal Ketorolac - used as directed for an appropriate, previously established indication<br>* Other names: Intranasal Ketorolac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Gynecologic Surgery, Female Pelvic Reconstructive Surgery, Post Operative Pain Control, Narcotic Reduction, Opioid Reduction, Pelvic Organ Prolapse, Stress Urinary Incontinence