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

Lead sponsor: University of Louisville

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:

1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:

1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)

2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol)

2. Patient satisfaction with the aforementioned methods

3. 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:

1. 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

2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4

3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1

4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4

5. Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score

6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home

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

Intervention type: Drug

Intervention name: Sprix

Description: Intranasal Ketorolac - used as directed for an appropriate, previously established indication

Arm group label: Sprix

Other name: Intranasal Ketorolac

Criteria:

Inclusion Criteria:

1. Age ≥ 18 years of age

2. Weight ≥ 110lbs

3. English Speaking and Reading

4. 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:

1. Patients taking opioids chronically at the time of surgery

2. History of Coronary Artery Bypass Graft (CABG)

3. History of peptic ulcer disease or bleeding in the stomach or intestines

4. History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID)

5. Uncontrolled hypertension at the time of consent and/or surgery

6. History of renal impairment as defined by blood creatinine of 1.1 or greater at any time

Gender: Female

Gender based: Yes

Gender description: Female patients - all patients in the study are those that will undergo/have undergone female pelvic surgery (Urogynecology)

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Last name: ZEBULUN COPE, DO

Phone: 8035303882

Email: [email protected]

United States

June 2020

Responsible party type: Principal Investigator

Investigator affiliation: University of Louisville

Investigator full name: Sean Francis

Investigator title: Chairperson & Professor

• Minimally Invasive Gynecologic Surgery
• Female Pelvic Reconstructive Surgery
• Post Operative Pain Control
• Narcotic Reduction
• Opioid Reduction
• Pelvic Organ Prolapse
• Stress Urinary Incontinence

• Urinary Incontinence
• Enuresis
• Urinary Incontinence, Stress
• Prolapse
• Pain, Postoperative
• Pelvic Organ Prolapse

Arm group label: Standard

Arm group type: No Intervention

Description: 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

Arm group label: Sprix

Arm group type: Experimental

Description: 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.

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This is a multi-center, non-blinded, randomized control trial.

Primary purpose: Treatment

Masking: None (Open Label)