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Sprix for Postoperative Pain Control Following Gynecologic Surgery

NCT04444830 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-07-29

No results posted yet for this study

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

Conditions

  • Post Operative Pain Control
  • Narcotic Use
  • Pelvic Organ Prolapse
  • Urinary Incontinence , Stress
  • Surgery

Interventions

DRUG

Sprix

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

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-09-21
Completion
2021-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444830 on ClinicalTrials.gov