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

NCT05386069 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NOMO Protocol
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Morphine Milligram Equivalents Used During Inpatient Stay

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

  from immediately postoperative through discharge or 4 weeks, whichever comes first

Secondary Outcomes (5)

• Passage of Voiding Trial

  from immediately postoperative through discharge or 4 weeks, whichever comes first

• Anti-emetic Use

  postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1

• Patient Pain Score

  postoperative day 7

• Prescription for Opioid at Discharge

  postoperative day 2 through postoperative day 7

• Length of Hospital Stay

  postoperative day 1 through discharge or 4 weeks, whichever comes first

Study Arms (2)

Control Arm

NO INTERVENTION

Routine Care per Anesthiologist/cRNA

Treatment Arm

ACTIVE COMPARATOR

Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail

Drug: NOMO Protocol

Interventions

NOMO Protocol DRUG

Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications

Also known as: Standard Care

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females undergoing Urogynecology procedure
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking females
• greater than or equal to 18 years old
• scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

• Reagan KML, O'Sullivan DM, Gannon R, Steinberg AC. Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Sep;217(3):325.e1-325.e10. doi: 10.1016/j.ajog.2017.05.041. Epub 2017 May 25.

  PMID: 28551445 RESULT

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Manager OBGYN Research
• Organization: Prisma Health

patti.parker@prismahealth.org

864-455-1510

Study Officials

• Hema Brazell, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: May 23, 2022
• Study Start: November 15, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)