Opioid Use
Conditions
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.
Interventions
DRUGNOMO Protocol
Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Milligram Equivalents Used During Inpatient Stay | from immediately postoperative through discharge or 4 weeks, whichever comes first | Total morphine milligram equivalents calculated for each patient during their stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Passage of Voiding Trial | from immediately postoperative through discharge or 4 weeks, whichever comes first | percentage of patients who pass voiding trial on POD#1 |
| Anti-emetic Use | postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1 | Did the patient require anti-emetics in the post-operative period |
| Patient Pain Score | postoperative day 7 | Evaluated via the Brief Pain Inventory (Short Form); rate pain on scale 0-10, 10 being worst |
| Prescription for Opioid at Discharge | postoperative day 2 through postoperative day 7 | Did the patient require a narcotic prescription |
| Length of Hospital Stay | postoperative day 1 through discharge or 4 weeks, whichever comes first | The average number of days patients were admitted as inpatient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Routine Care per Anesthiologist/cRNA | 5 |
| 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 | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Control Arm | Treatment Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Brief Pain Inventory (Short Form) | 4.8 units on a scale | 2.4 units on a scale | 3.6 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Morphine Milligram Equivalents Used During Inpatient Stay
Total morphine milligram equivalents calculated for each patient during their stay.
Time frame: from immediately postoperative through discharge or 4 weeks, whichever comes first
Population: Patients undergoing urogynecologic procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Morphine Milligram Equivalents Used During Inpatient Stay | 10.8 morhpine milligram equivalents | Standard Deviation 5.6 |
| Treatment Arm | Morphine Milligram Equivalents Used During Inpatient Stay | 8.8 morhpine milligram equivalents | Standard Deviation 7.1 |
Secondary
Anti-emetic Use
Did the patient require anti-emetics in the post-operative period
Time frame: postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Anti-emetic Use | 5 Participants |
| Treatment Arm | Anti-emetic Use | 5 Participants |
Secondary
Length of Hospital Stay
The average number of days patients were admitted as inpatient.
Time frame: postoperative day 1 through discharge or 4 weeks, whichever comes first
Population: All enrolled patients included - all patients stayed in hospital for 2 days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Arm | Length of Hospital Stay | 2 days |
| Treatment Arm | Length of Hospital Stay | 2 days |
Secondary
Passage of Voiding Trial
percentage of patients who pass voiding trial on POD#1
Time frame: from immediately postoperative through discharge or 4 weeks, whichever comes first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Passage of Voiding Trial | 4 Participants |
| Treatment Arm | Passage of Voiding Trial | 4 Participants |
Secondary
Patient Pain Score
Evaluated via the Brief Pain Inventory (Short Form); rate pain on scale 0-10, 10 being worst
Time frame: postoperative day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Patient Pain Score | 4.8 score on a scale |
| Treatment Arm | Patient Pain Score | 2.4 score on a scale |
Secondary
Prescription for Opioid at Discharge
Did the patient require a narcotic prescription
Time frame: postoperative day 2 through postoperative day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Prescription for Opioid at Discharge | 4 Participants |
| Treatment Arm | Prescription for Opioid at Discharge | 1 Participants |