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Sprix for Postoperative Pain Control Following Gynecologic Surgery

Primary Purpose

Post Operative Pain Control, Narcotic Use, Pelvic Organ Prolapse

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sprix
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain Control focused on measuring Minimally Invasive Gynecologic Surgery, Female Pelvic Reconstructive Surgery, Post Operative Pain Control, Narcotic Reduction, Opioid Reduction, Pelvic Organ Prolapse, Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Louisville Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Sprix

Arm 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

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.

Outcomes

Primary Outcome Measures

Morphine mEqs
The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents

Secondary Outcome Measures

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
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

Full Information

First Posted
June 7, 2020
Last Updated
July 27, 2022
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT04444830
Brief Title
Sprix for Postoperative Pain Control Following Gynecologic Surgery
Official Title
Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study never opened to enrollment. Study never IRB approved.
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain Control, Narcotic Use, Pelvic Organ Prolapse, Urinary Incontinence , Stress, Surgery
Keywords
Minimally Invasive Gynecologic Surgery, Female Pelvic Reconstructive Surgery, Post Operative Pain Control, Narcotic Reduction, Opioid Reduction, Pelvic Organ Prolapse, Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-center, non-blinded, randomized control trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm 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 Title
Sprix
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sprix
Other Intervention Name(s)
Intranasal Ketorolac
Intervention Description
Intranasal Ketorolac - used as directed for an appropriate, previously established indication
Primary Outcome Measure Information:
Title
Morphine mEqs
Description
The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents
Time Frame
As measured from the day of surgery to 4 days post operative
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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
Time Frame
Day of surgery to 4 days postoperative
Title
Patient's perception of current pain
Description
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
Time Frame
Day of surgery to 4 days postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients - all patients in the study are those that will undergo/have undergone female pelvic surgery (Urogynecology)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20557145
Citation
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. Erratum In: Curr Med Res Opin. 2012 Jun;28(6):1052.
Results Reference
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PubMed Identifier
25169467
Citation
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.
Results Reference
background
PubMed Identifier
26782787
Citation
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.
Results Reference
background
PubMed Identifier
19020154
Citation
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. Erratum In: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.
Results Reference
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Sprix for Postoperative Pain Control Following Gynecologic Surgery

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