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NCT04970069

Preoperative Education

Completed NA Results posted Last updated 25 July 2024
What this trial tests

NA trial testing Video on analgesic education in Postoperative Pain in 1,057 participants. Completed in 15 September 2023.

Timeline
25 July 2021
Primary endpoint
15 September 2023
15 September 2023

Quick facts

Lead sponsorThe Cleveland Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment1,057
Start date25 July 2021
Primary completion15 September 2023
Estimated completion15 September 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Consumption Primary · 72 hours after surgery

Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.

GroupValue95% CI
Analgesic Education2313 – 42
General Perioperative Education2610 – 45
Time-weighted Average Pain Scores Secondary · 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.

GroupValue95% CI
Analgesic Education43 – 5
General Perioperative Education43 – 5
Satisfaction With Post Operative Pain Management Secondary · 3 days after surgery

Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.

GroupValue95% CI
Analgesic Education98 – 10
General Perioperative Education108 – 10

Adverse events — posted to ClinicalTrials.gov

Time frame: 72 hours after surgery or until discharge, whichever was earlier.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Analgesic Education
Serious: 0/483 (0%)
Deaths: 0/483
General Perioperative Education
Serious: 0/474 (0%)
Deaths: 2/474
Other adverse events (4 terms — click to expand)

ReactionSystemAnalgesic EducationGeneral Perioperative Educ…
Anti-emetic useGastrointestinal disorders——
Nausea and vomitingGastrointestinal disorders——
IleusGastrointestinal disorders——
Urinary catheterizationRenal and urinary disorders——

Data from ClinicalTrials.gov NCT04970069 adverse events section.

Sponsor's own description

The investigators will evaluate the effect of preoperative education on postoperative opioid.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Postoperative Pain

Currently open trials in the same condition.

Other The Cleveland Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04970069.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing