Sprix for Postoperative Pain Control Following Gynecologic Surgery

Phase 4

Withdrawn

• Conditions: Urinary Incontinence , Stress; Pelvic Organ Prolapse; Post Operative Pain Control; Narcotic Use; Surgery
• Interventions: Drug: Sprix

• Registration Number: NCT04444830
• Lead Sponsor: University of Louisville

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:

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2021-01
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sprix	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States