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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid Use

Intervention / Treatment
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* Drug: NOMO Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 
| 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 | 
| Prescription for Opioid at Discharge | Did the patient require a narcotic prescription | postoperative day 2 through postoperative day 7 | 
| Length of Hospital Stay | How many days was the patient inpatient | postoperative day 1 through discharge or 4 weeks, whichever comes first |