Opioid Misuse and Addiction, Pain
Conditions
Brief summary
Investigators have created an opioid reduction package which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.
Detailed description
Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however patients were not provided opioid prescriptions at discharge. Two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.
Interventions
DRUGOxycodone
Investigators provided set opioid prescriptions for 10 pills each patient.
BEHAVIORALZero Opioid Protocol
Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
Sponsors
Thomas Jefferson University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Control group, opioid sparing arm, and zero opioid arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Opioid naïve patients * Age \> 18 * Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy
Exclusion criteria
* Urgent/emergent status * Previous cholecystostomy tube placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Milligram Equivalents Taken by Participants | 14 days | Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Scores Ranging From 1 - 10 | 14 days | Patient will be asked to rank their satisfaction scores on a scale from 1 - 10 (with 1 being extremely dissatisfied and 10 being extremely satisfied) since discharge from the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Normal standard practices | 58 |
| Opioid Sparing Providers required to prescribe 10 narcotic pills only
Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient. | 42 |
| Zero Opioid No narcotic prescription is provided to patient at discharge
Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control. | 29 |
| Total | 129 |
Baseline characteristics
| Characteristic | Control | Opioid Sparing | Zero Opioid | Total |
|---|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 1.8 | 55.3 years STANDARD_DEVIATION 2 | 58.6 years STANDARD_DEVIATION 2.9 | 54 years STANDARD_DEVIATION 3.4 |
| BMI | 27.8 kg/m^2 | 27.9 kg/m^2 | 25.4 kg/m^2 | 27 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 31 Participants | 22 Participants | 100 Participants |
| Region of Enrollment United States | 58 participants | 42 participants | 29 participants | 129 participants |
| Sex: Female, Male Female | 19 Participants | 10 Participants | 2 Participants | 31 Participants |
| Sex: Female, Male Male | 39 Participants | 32 Participants | 27 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 42 | 0 / 29 |
| other Total, other adverse events | 0 / 58 | 0 / 42 | 0 / 29 |
| serious Total, serious adverse events | 0 / 58 | 0 / 42 | 0 / 29 |
Outcome results
Primary
Morphine Milligram Equivalents Taken by Participants
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Morphine Milligram Equivalents Taken by Participants | 46 morphine milligram equivalents |
| Opioid Sparing | Morphine Milligram Equivalents Taken by Participants | 15 morphine milligram equivalents |
| Zero Opioid | Morphine Milligram Equivalents Taken by Participants | 0 morphine milligram equivalents |
Secondary
Satisfaction Scores Ranging From 1 - 10
Patient will be asked to rank their satisfaction scores on a scale from 1 - 10 (with 1 being extremely dissatisfied and 10 being extremely satisfied) since discharge from the hospital
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Satisfaction Scores Ranging From 1 - 10 | 10 units on a scale |
| Opioid Sparing | Satisfaction Scores Ranging From 1 - 10 | 10 units on a scale |
| Zero Opioid | Satisfaction Scores Ranging From 1 - 10 | 10 units on a scale |