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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386069
• Other study ID #: NOMO Protocol
• Status: Completed
• Phase: Phase 3
• Start date: November 15, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

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

Locations

Country	Name	City	State
United States	Prisma Health - Upstate	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Milligram Equivalents used during inpatient stay	Opioid usage will change during the postoperative period	from immediately postoperative through discharge or 4 weeks, whichever comes first
Secondary	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
Secondary	Anti-emetic use	Did the patient require anti-emetics in the post-operative period	from immediately postoperative through discharge or 4 weeks, whichever comes first
Secondary	Patient satisfaction score	Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst	postoperative day 2 and postoperative day 7
Secondary	Prescription for Opioid at Discharge	Did the patient require a narcotic prescription	postoperative day 2 through postoperative day 7
Secondary	Length of Hospital Stay	How many days was the patient inpatient	postoperative day 1 through discharge or 4 weeks, whichever comes first