Sprix for Postoperative Pain Control Following Gynecologic Surgery

NCT04444830 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 19.1351
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:
2. 2.Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)
3. 3.Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol)
4. 4.Patient satisfaction with the aforementioned methods
5. 5.Evaluate and compare pain scores via validated questionnaire
6. 6.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
7. 7.Patients in the Sprix protocol will have lower numeric pain score and on POD#4
8. 8.Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1
9. 9.Patients in the Sprix protocol will have higher QoR-40 scores on POD#4
10. 10.Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score
11. 11.Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satisfaction

  Day of surgery to 4 days postoperative

• Patient's perception of current pain

  Day of surgery to 4 days postoperatively

Study Arms (2)

Standard

NO INTERVENTION

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

Sprix

EXPERIMENTAL

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

Interventions

Sprix DRUG

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

Also known as: Intranasal Ketorolac

Sprix

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients - all patients in the study are those that will undergo/have undergone female pelvic surgery (Urogynecology)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40203, United States

Location

Related Publications (4)

• 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.

  PMID: 20557145 BACKGROUND

• 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.

  PMID: 25169467 BACKGROUND

• 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.

  PMID: 26782787 BACKGROUND

• 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.

  PMID: 19020154 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson & Professor

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

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 24, 2020
• Study Start: January 1, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: July 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)