Trial Outcomes & Findings for Preoperative Education (NCT NCT04970069)
NCT ID: NCT04970069
Last Updated: 2024-07-25
Results Overview
Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1057 participants
Primary outcome timeframe
72 hours after surgery
Results posted on
2024-07-25
Participant Flow
Participant milestones
| Measure |
Analgesic Education
Video on analgesic education: A four minute video informing the patient about opioids.
|
General Perioperative Education
Video on general perioperative education: A four minute video informing the patient about general perioperative process.
|
|---|---|---|
|
Overall Study
STARTED
|
527
|
530
|
|
Overall Study
COMPLETED
|
483
|
474
|
|
Overall Study
NOT COMPLETED
|
44
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
Baseline characteristics by cohort
| Measure |
Analgesic Education
n=527 Participants
Video on analgesic education: A four minute video informing the patient about opioids.
|
General Perioperative Education
n=530 Participants
Video on general perioperative education: A four minute video informing the patient about general perioperative process.
|
Total
n=1057 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 15 • n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
60 years
STANDARD_DEVIATION 15 • n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
60 years
STANDARD_DEVIATION 15 • n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Sex: Female, Male
Female
|
193 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
198 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
391 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Sex: Female, Male
Male
|
290 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
276 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
566 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Race/Ethnicity, Customized
Black
|
67 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
55 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
122 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Race/Ethnicity, Customized
White
|
388 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
393 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
781 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Race/Ethnicity, Customized
Other
|
28 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
26 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
54 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Region of Enrollment
United States
|
527 participants
n=527 Participants
|
530 participants
n=530 Participants
|
1057 participants
n=1057 Participants
|
|
History of chronic pain
|
15 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
20 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
35 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Type of surgery
Laparoscopic colorectal
|
24 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
21 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
45 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Type of surgery
Orthopedic
|
51 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
63 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
114 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
|
Type of surgery
Laparoscopic abdominal
|
408 Participants
n=483 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
390 Participants
n=474 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
798 Participants
n=957 Participants • Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.
|
PRIMARY outcome
Timeframe: 72 hours after surgeryPopulation: Modified intention to treat analysis population
Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.
Outcome measures
| Measure |
Analgesic Education
n=483 Participants
Video on analgesic education: A four minute video informing the patient about opioids.
|
General Perioperative Education
n=474 Participants
Video on general perioperative education: A four minute video informing the patient about general perioperative process.
|
|---|---|---|
|
Opioid Consumption
|
23 Morphine milligrams equivalent
Interval 13.0 to 42.0
|
26 Morphine milligrams equivalent
Interval 10.0 to 45.0
|
SECONDARY outcome
Timeframe: 72 hours after surgery, or until discharge, whichever was earlierPopulation: Modified intention to treat population
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.
Outcome measures
| Measure |
Analgesic Education
n=483 Participants
Video on analgesic education: A four minute video informing the patient about opioids.
|
General Perioperative Education
n=474 Participants
Video on general perioperative education: A four minute video informing the patient about general perioperative process.
|
|---|---|---|
|
Time-weighted Average Pain Scores
|
4 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 3 days after surgeryPatient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.
Outcome measures
| Measure |
Analgesic Education
n=483 Participants
Video on analgesic education: A four minute video informing the patient about opioids.
|
General Perioperative Education
n=474 Participants
Video on general perioperative education: A four minute video informing the patient about general perioperative process.
|
|---|---|---|
|
Satisfaction With Post Operative Pain Management
|
9 score on a scale
Interval 8.0 to 10.0
|
10 score on a scale
Interval 8.0 to 10.0
|
Adverse Events
Analgesic Education
Serious events: 0 serious events
Other events: 181 other events
Deaths: 0 deaths
General Perioperative Education
Serious events: 0 serious events
Other events: 176 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Analgesic Education
n=483 participants at risk
Video on analgesic education: A four minute video informing the patient about opioids.
|
General Perioperative Education
n=474 participants at risk
Video on general perioperative education: A four minute video informing the patient about general perioperative process.
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
5.6%
27/483 • 72 hours after surgery or until discharge, whichever was earlier.
|
4.9%
23/474 • 72 hours after surgery or until discharge, whichever was earlier.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
4.6%
22/483 • 72 hours after surgery or until discharge, whichever was earlier.
|
5.9%
28/474 • 72 hours after surgery or until discharge, whichever was earlier.
|
|
Renal and urinary disorders
Urinary catheterization
|
3.1%
15/483 • 72 hours after surgery or until discharge, whichever was earlier.
|
5.5%
26/474 • 72 hours after surgery or until discharge, whichever was earlier.
|
|
Gastrointestinal disorders
Anti-emetic use
|
32.3%
156/483 • 72 hours after surgery or until discharge, whichever was earlier.
|
32.7%
155/474 • 72 hours after surgery or until discharge, whichever was earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place