NCT04625868

Brief Summary

This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

July 3, 2020

Last Update Submit

September 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morphine milliequivalents consumed in 2 weeks postoperatively

    Total morphine mEq consumed in 2 weeks after surgery

    2 weeks after surgery

Secondary Outcomes (3)

  • Visual Analog Scale

    2 weeks after surgery

  • Patient satisfaction

    7-10 days after surgery

  • Proper disposal

    2 weeks after surgery

Study Arms (4)

Soft tissue surgery - preoperative video

EXPERIMENTAL

Patients \> 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.

Other: Educational video

Soft tissue surgery - no video

NO INTERVENTION

Patients \> 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.

Bone/joint surgery - preoperative video

EXPERIMENTAL

Patients \> 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.

Other: Educational video

Bone/joint surgery - no video

NO INTERVENTION

Patients \> 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.

Interventions

Patients will watch a preoperative educational video on proper opioid use and disposal.

Bone/joint surgery - preoperative videoSoft tissue surgery - preoperative video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing elective hand surgery
  • surgeon is planning to prescribe opioids for postoperative pain control

You may not qualify if:

  • emergent surgery
  • surgeon not planning to prescribe opioids for postoperative pain control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hand InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David M. Kalainov, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

July 3, 2020

First Posted

November 12, 2020

Study Start

May 29, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations