- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04138264
Opioid Counseling Following Orthopaedic Surgery
October 23, 2019 updated by: Rothman Institute Orthopaedics
Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling
Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use.
A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries.
The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
237
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19148
- Rothman Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery
Exclusion Criteria:
- male of female less than 18 years old
- patients schedule to undergo inpatient procedures
- patients undergoing surgeries distal to the wrist
- patients undergoing surgeries under local anesthesia only
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Peroperative counseling
|
preoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet.
The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed.
|
No Intervention: No preoperative counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of pills consumed
Time Frame: Up to 6 weeks
|
Patients asked to keep daily diary which includes number of pills consumed during the post-operative period
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine equivalents (MEQ)
Time Frame: Up to 6 weeks
|
MEQs is a standardized method of comparing different types of pain medication with a gold-standard.
All pain medication can be converted to MEQs
|
Up to 6 weeks
|
Visual Analog Scale (pain) Pain
Time Frame: Up to 6 weeks
|
Pain as reported by patients on a daily basis via diaries
|
Up to 6 weeks
|
Patient satisfaction with pain management: 5 point Likert Scale
Time Frame: Up to 6 weeks
|
Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale
|
Up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2018
Primary Completion (Actual)
November 2, 2018
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
October 21, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (Actual)
October 24, 2019
Study Record Updates
Last Update Posted (Actual)
October 24, 2019
Last Update Submitted That Met QC Criteria
October 23, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ilyas2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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