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Sprix for Post Operative Pain Management

Phase 4
Waitlist Available
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery to 4 days postoperative
Awards & highlights

Study Summary

This trial is testing whether using a different mix of drugs to manage post-operative pain (acetaminophen, ibuprofen, and intranasal ketorolac instead of just acetaminophen and ibuprofen) will lead to patients using fewer opioids and being more satisfied with their pain management.

Eligible Conditions
  • Post Operative Pain Management
  • Stress Incontinence
  • Drug Abuse
  • Pelvic Organ Prolapse
  • Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery to 4 days postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery to 4 days postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morphine mEqs
Secondary outcome measures
Patient Satisfaction
Patient's perception of current pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SprixExperimental Treatment1 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 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.
Group II: StandardActive Control1 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

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,984 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Anesthesia & AnalgesiaJournal
The Safety and Analgesic Efficacy of Intranasal Ketorolac in Patients with Postoperative Pain
Moodie, John E., Colin R. Brown, Eileen J. Bisley, Hans U. Weber, and Lincoln Bynum. 2008. “The Safety and Analgesic Efficacy of Intranasal Ketorolac in Patients with Postoperative Pain”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e318188b736.
clinicaltrials.govStudy
Sprix for Postoperative Pain Control Following Gynecologic Surgery
Sean Francis, MD 2021. "Sprix for Postoperative Pain Control Following Gynecologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04444830.
~0 spots leftby Apr 2025
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