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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Routine Care per Anesthiologist/cRNA | |
| Treatment Arm | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOMO Protocol | Drug | Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Milligram Equivalents Used During Inpatient Stay | Total morphine milligram equivalents calculated for each patient during their stay. | from immediately postoperative through discharge or 4 weeks, whichever comes first |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Females undergoing Urogynecology procedure
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| Name | Affiliation | Role |
|---|---|---|
| Hema Brazell, MD | Prisma Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health - Upstate | Greenville | South Carolina | 29615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28551445 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Routine Care per Anesthiologist/cRNA |
| FG001 | 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 NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Routine Care per Anesthiologist/cRNA |
| BG001 | 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 NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Milligram Equivalents Used During Inpatient Stay | Total morphine milligram equivalents calculated for each patient during their stay. | Patients undergoing urogynecologic procedure. | Posted | Mean | Standard Deviation | morhpine milligram equivalents | from immediately postoperative through discharge or 4 weeks, whichever comes first |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Routine Care per Anesthiologist/cRNA | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager OBGYN Research | Prisma Health | 864-455-1510 | patti.parker@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2019 | Jun 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomized Control Trial
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| postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1 |
| Patient Pain Score | Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst | 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 | The average number of days patients were admitted as inpatient. | postoperative day 1 through discharge or 4 weeks, whichever comes first |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Brief Pain Inventory (Short Form) | Median | Full Range | units on a scale |
|
|
|
| Secondary | Passage of Voiding Trial | percentage of patients who pass voiding trial on POD#1 | Posted | Count of Participants | Participants | from immediately postoperative through discharge or 4 weeks, whichever comes first |
|
|
|
| Secondary | Anti-emetic Use | Did the patient require anti-emetics in the post-operative period | Posted | Count of Participants | Participants | postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1 |
|
|
|
| Secondary | Patient Pain Score | Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst | Posted | Median | Full Range | score on a scale | postoperative day 7 |
|
|
|
| Secondary | Prescription for Opioid at Discharge | Did the patient require a narcotic prescription | Posted | Count of Participants | Participants | postoperative day 2 through postoperative day 7 |
|
|
|
| Secondary | Length of Hospital Stay | The average number of days patients were admitted as inpatient. | All enrolled patients included - all patients stayed in hospital for 2 days. | Posted | Mean | Full Range | days | postoperative day 1 through discharge or 4 weeks, whichever comes first |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications | 0 | 5 | 0 | 5 | 0 | 5 |
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