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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-06-01

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.

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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.

Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Arm

Routine Care per Anesthiologist/cRNA

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment Arm

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

Group Type ACTIVE_COMPARATOR

NOMO Protocol

Intervention Type DRUG

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

Interventions

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NOMO Protocol

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

Intervention Type DRUG

Other Intervention Names

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Standard Care

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes