Sprix for Postoperative Pain Control Following Gynecologic Surgery

Sponsor

University of Louisville (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04444830

Collaborator

(none)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Control Narcotic Use Pelvic Organ Prolapse Urinary Incontinence , Stress Surgery	Drug: Sprix	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a multi-center, non-blinded, randomized control trial.This is a multi-center, non-blinded, randomized control trial.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Sep 21, 2021

Actual Study Completion Date :

Sep 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard 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 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 Other Names: Intranasal Ketorolac

Arm

Intervention/Treatment

No Intervention: Standard

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

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

Other Names:

Intranasal Ketorolac

Outcome Measures

Primary Outcome Measures

Morphine mEqs [As measured from the day of surgery to 4 days post operative]
The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents

Secondary Outcome Measures

Patient Satisfaction [Day of surgery to 4 days postoperative]
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
Patient's perception of current pain [Day of surgery to 4 days postoperatively]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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