Postoperative Pain
Conditions
Brief summary
The investigators will evaluate the effect of preoperative education on postoperative opioid.
Detailed description
The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.
Interventions
OTHERVideo on analgesic education
A four minute video informing the patient about opioids.
OTHERVideo on general perioperative education
A four minute video informing the patient about general perioperative process.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Modified informed consent * Adults ≥18 years * American Society of Anaesthesiologists physical status 1-4 * Scheduled for hip arthroplasty, laparoscopy assisted colorectal surgery * Personal visit the PACE clinic * Anticipated overnight postoperative hospitalization * Reasonable English fluency
Exclusion criteria
* Opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent * Regional block or epidural analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 72 hours after surgery | Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Average Pain Scores | 72 hours after surgery, or until discharge, whichever was earlier | Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward. |
| Satisfaction With Post Operative Pain Management | 3 days after surgery | Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Analgesic Education Video on analgesic education: A four minute video informing the patient about opioids. | 527 |
| General Perioperative Education Video on general perioperative education: A four minute video informing the patient about general perioperative process. | 530 |
| Total | 1,057 |
Baseline characteristics
| Characteristic | Analgesic Education | General Perioperative Education | Total |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 15 | 60 years STANDARD_DEVIATION 15 | 60 years STANDARD_DEVIATION 15 |
| History of chronic pain | 15 Participants | 20 Participants | 35 Participants |
| Race/Ethnicity, Customized Black | 67 Participants | 55 Participants | 122 Participants |
| Race/Ethnicity, Customized Other | 28 Participants | 26 Participants | 54 Participants |
| Race/Ethnicity, Customized White | 388 Participants | 393 Participants | 781 Participants |
| Region of Enrollment United States | 527 participants | 530 participants | 1057 participants |
| Sex: Female, Male Female | 193 Participants | 198 Participants | 391 Participants |
| Sex: Female, Male Male | 290 Participants | 276 Participants | 566 Participants |
| Type of surgery Laparoscopic abdominal | 408 Participants | 390 Participants | 798 Participants |
| Type of surgery Laparoscopic colorectal | 24 Participants | 21 Participants | 45 Participants |
| Type of surgery Orthopedic | 51 Participants | 63 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 483 | 2 / 474 |
| other Total, other adverse events | 181 / 483 | 176 / 474 |
| serious Total, serious adverse events | 0 / 483 | 0 / 474 |
Outcome results
Primary
Opioid Consumption
Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.
Time frame: 72 hours after surgery
Population: Modified intention to treat analysis population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Analgesic Education | Opioid Consumption | 23 Morphine milligrams equivalent |
| General Perioperative Education | Opioid Consumption | 26 Morphine milligrams equivalent |
Comparison: Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.p-value: 0.8995% CI: [0.86, 1.18]Regression, Linear
Secondary
Satisfaction With Post Operative Pain Management
Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.
Time frame: 3 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Analgesic Education | Satisfaction With Post Operative Pain Management | 9 score on a scale |
| General Perioperative Education | Satisfaction With Post Operative Pain Management | 10 score on a scale |
p-value: 0.61195% CI: [-0.3, 0.2]Regression, Linear
Secondary
Time-weighted Average Pain Scores
Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward.
Time frame: 72 hours after surgery, or until discharge, whichever was earlier
Population: Modified intention to treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Analgesic Education | Time-weighted Average Pain Scores | 4 score on a scale |
| General Perioperative Education | Time-weighted Average Pain Scores | 4 score on a scale |
p-value: 0.61795% CI: [-0.3, 0.2]Regression, Linear