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OpenTrials
Completed

NCT Number: NCT05386069

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOMO Protocol

Drug

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

Other names: Standard Care

Primary outcomes

  1. Morphine Milligram Equivalents Used During Inpatient Stay

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

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

Secondary outcomes

  1. Passage of Voiding Trial

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

    percentage of patients who pass voiding trial on POD#1

  2. Anti-emetic Use

    Time frame: 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

  3. Patient Pain Score

    Time frame: postoperative day 7

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

  4. Prescription for Opioid at Discharge

    Time frame: postoperative day 2 through postoperative day 7

    Did the patient require a narcotic prescription

  5. Length of Hospital Stay

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

    The average number of days patients were admitted as inpatient.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 23, 2022
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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