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NCT05386069

Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use

Completed Phase 3 Results posted Last updated 23 May 2025
What this trial tests

Phase 3 trial testing NOMO Protocol in Opioid Use in 10 participants. Completed in 1 June 2021.

Timeline
15 November 2019
Primary endpoint
1 December 2020
1 June 2021

Quick facts

Lead sponsorPrisma Health-Upstate
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment10
Start date15 November 2019
Primary completion1 December 2020
Estimated completion1 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Prisma Health-Upstate — full company profile →

Who can join

18 and older, female only, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Morphine Milligram Equivalents Used During Inpatient Stay Primary · from immediately postoperative through discharge or 4 weeks, whichever comes first

Total morphine milligram equivalents calculated for each patient during their stay.

GroupValue95% CI
Control Arm10.8± 5.6
Treatment Arm8.8± 7.1
Passage of Voiding Trial Secondary · from immediately postoperative through discharge or 4 weeks, whichever comes first

percentage of patients who pass voiding trial on POD#1

GroupValue95% CI
Control Arm4
Treatment Arm4
Anti-emetic Use Secondary · postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1

Did the patient require anti-emetics in the post-operative period

GroupValue95% CI
Control Arm5
Treatment Arm5
Patient Pain Score Secondary · postoperative day 7

Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst

GroupValue95% CI
Control Arm4.80 – 10
Treatment Arm2.40 – 10
Prescription for Opioid at Discharge Secondary · postoperative day 2 through postoperative day 7

Did the patient require a narcotic prescription

GroupValue95% CI
Control Arm4
Treatment Arm1
Length of Hospital Stay Secondary · postoperative day 1 through discharge or 4 weeks, whichever comes first

The average number of days patients were admitted as inpatient.

GroupValue95% CI
Control Arm22 – 2
Treatment Arm22 – 2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Opioid Use

Currently open trials in the same condition.

Other Prisma Health-Upstate trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05386069.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing