Clinical trial NCT05386069: Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use
Official title: The Effect of a Non-Opioid Multimodal Pain (NOMO) Protocol in Decreasing Narcotic Use After Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine Milligram Equivalents Used During Inpatient Stay
timeFrame: from immediately postoperative through discharge or 4 weeks, whichever comes first
Secondary outcomes:
measure: Passage of Voiding Trial
timeFrame: from immediately postoperative through discharge or 4 weeks, whichever comes first
measure: Anti-emetic Use
timeFrame: postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1
measure: Patient Pain Score
timeFrame: postoperative day 7
measure: Prescription for Opioid at Discharge
timeFrame: postoperative day 2 through postoperative day 7
measure: Length of Hospital Stay
timeFrame: postoperative day 1 through discharge or 4 weeks, whichever comes first
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Hema Brazell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.