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

The Effect of a Non-Opioid Multimodal Pain (NOMO) Protocol in Decreasing Narcotic Use After Urogynecologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Drug: NOMO Protocol

Detailed 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. NOMO protocols seek to reduce the opioid usage for patients in the postoperative period. Patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. These medications are approved for pain control; but they have few side effects and less addictive properties. 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health - Upstate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Routine Care per Anesthiologist/cRNA
Active Comparator: Treatment Arm; 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; Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications; Other Names: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passage of Voiding Trial	percentage of patients who pass voiding trial on POD#1	from immediately postoperative through discharge or 4 weeks, whichever comes first
Prescription for Opioid at Discharge	Did the patient require a narcotic prescription	postoperative day 2 through postoperative day 7
Anti-emetic Use	Did the patient require anti-emetics in the post-operative period	postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1
Patient Pain Score	Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst	postoperative day 7
Length of Hospital Stay	The average number of days patients were admitted as inpatient.	postoperative day 1 through discharge or 4 weeks, whichever comes first

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Hema Brazell, MD, Prisma Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NOMO Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No