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

Phase 3
Completed
Conditions
Opioid Use
Interventions
Drug: NOMO Protocol
Registration Number
NCT05386069
Lead Sponsor
Prisma Health-Upstate
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
11
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment ArmNOMO ProtocolPatients 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
Primary Outcome Measures
NameTimeMethod
Morphine Milligram Equivalents used during inpatient stayfrom immediately postoperative through discharge or 4 weeks, whichever comes first

Opioid usage will change during the postoperative period

Secondary Outcome Measures
NameTimeMethod
Patient satisfaction scorepostoperative day 2 and postoperative day 7

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

Passage of Voiding Trialfrom immediately postoperative through discharge or 4 weeks, whichever comes first

percentage of patients who pass voiding trial on POD#1

Prescription for Opioid at Dischargepostoperative day 2 through postoperative day 7

Did the patient require a narcotic prescription

Length of Hospital Staypostoperative day 1 through discharge or 4 weeks, whichever comes first

How many days was the patient inpatient

Anti-emetic usefrom immediately postoperative through discharge or 4 weeks, whichever comes first

Did the patient require anti-emetics in the post-operative period

Trial Locations

Locations (1)

Prisma Health - Upstate

🇺🇸

Greenville, South Carolina, United States

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