Phase 3
N=10
Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use
Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT05386069 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Morphine Milligram Equivalents Used During Inpatient Stay — 10.8; 8.8 morhpine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NOMO Protocol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Prisma Health-Upstate
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphine Milligram Equivalents Used During Inpatient Stay |
10.8; 8.8 | — |
| SECONDARY Passage of Voiding Trial |
4; 4 | — |
| SECONDARY Anti-emetic Use |
5; 5 | — |
| SECONDARY Patient Pain Score |
4.8; 2.4 | — |
| SECONDARY Prescription for Opioid at Discharge |
4; 1 | — |
| SECONDARY Length of Hospital Stay |
2; 2 | — |
Summary
The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.
Eligibility Criteria
Inclusion Criteria
- English-speaking females
- greater than or equal to 18 years old
- scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.
Exclusion Criteria
- less than 18 years of age
- non-English speaking patients
- unscheduled urogynecologic surgeries
- patients expected to undergo a simple reconstructive surgery with same-day discharge,
- history of chronic pain
- chronic Lyrica or Celebrex use
- psychiatric disorder, narcotic dependence or narcotic prescription in the past six weeks
- current liver disease
- kidney disease (defined as GFR <60)
- malignancy
- sulfa allergy
Data sourced from ClinicalTrials.gov (NCT05386069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.