NCT03105791

Brief Summary

Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

April 4, 2017

Last Update Submit

April 4, 2017

Conditions

Rotator Cuff Injury

Outcome Measures

Primary Outcomes (1)

  • Opioid Usage

    count of total narcotic pills not taken by patients

    3 months

Study Arms (2)

Normal pre-operative education

NO INTERVENTION

• Control group received normal pre-operative education regarding surgery

Opioid usage education

ACTIVE COMPARATOR

• The study group received formal education detailing recommended post-operative opioid usage, side effects, dependence, and addiction

Other: Formal education regarding opioid usage

Interventions

Formal education regarding opioid usageOTHER

Participannts watched a 2 minute video and were given educational materials

Opioid usage education

Eligibility Criteria

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

You may qualify if:

  • Over the age of 18
  • clinically indicated for an arthroscopic rotator cuff repair

You may not qualify if:

  • Patients with irreparable rotator cuff tears
  • allergic or sensitivity to the study medication
  • history of gastrointestinal issues
  • any evidence of glenohumeral arthritis
  • inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 10, 2017

Record last verified: 2017-04