Total morphine milligram equivalents calculated for each patient during their stay.
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 10.8 | ± 5.6 |
| Treatment Arm | 8.8 | ± 7.1 |
Last reviewed · How we verify
Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use
Phase 3 trial testing NOMO Protocol in Opioid Use in 10 participants. Completed in 1 June 2021.
| Lead sponsor | Prisma Health-Upstate |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 10 |
| Start date | 15 November 2019 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across United States |
Prisma Health-Upstate — full company profile →
18 and older, female only, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total morphine milligram equivalents calculated for each patient during their stay.
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 10.8 | ± 5.6 |
| Treatment Arm | 8.8 | ± 7.1 |
percentage of patients who pass voiding trial on POD#1
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 4 | |
| Treatment Arm | 4 |
Did the patient require anti-emetics in the post-operative period
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 5 | |
| Treatment Arm | 5 |
Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 4.8 | 0 – 10 |
| Treatment Arm | 2.4 | 0 – 10 |
Did the patient require a narcotic prescription
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 4 | |
| Treatment Arm | 1 |
The average number of days patients were admitted as inpatient.
| Group | Value | 95% CI |
|---|---|---|
| Control Arm | 2 | 2 – 2 |
| Treatment Arm | 2 | 2 – 2 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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