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

Prisma Health-Upstate

Status and phase: Completed; Phase 3

Conditions: Opioid Use

Treatments: Drug: NOMO Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05386069

NOMO Protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Routine Care per Anesthiologist/cRNA

Treatment Arm

Active Comparator group

Description:

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

Treatment:

Drug: NOMO Protocol