Opioid Consumption After Orthopaedic Surgery
Primary Purpose
Orthopedic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-operative opioid counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Orthopedic Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients indicated to undergo outpatient orthopedic surgery in one of the four areas included in the study (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery).
- Age eligibility is > 18 years of age.
Exclusion Criteria:
- Inpatient procedures.
- Pediatric patients (age < 18 years).
- Known allergy to narcotic medication.
- Pregnant female patients.
- Non-English speaking patients
- History of chronic pain and/or narcotic use preoperatively.
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Opioid counseling group
No Counseling
Arm Description
Counseling provided to patients prior to surgery regarding opioid usage, side effect, long term effect and risks of opioids.
No preoperative counseling will be provided to this group. Standard medication information will be provided only.
Outcomes
Primary Outcome Measures
Post operative opioid consumption
The primary outcome measure will be post operative opioid consumption.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03173131
Brief Title
Opioid Consumption After Orthopaedic Surgery
Official Title
Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized controlled study that will involve fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery) within our practice group. Consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). The control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative opioid counseling.
Detailed Description
Over the past two decades in the United States, the opioid epidemic has escalated at a startling rate and prescription opioids are a large contributor to this problem. Studies show that there is an excessive amount of opioids being prescribed for orthopedic procedures. An accurate understanding of opioid consumption following common outpatient orthopedic surgery is imperative in order to treat pain appropriately relative to the surgery being performed without leading to excess narcotic prescribing.
The purpose of the study is threefold: to better understand typical opioid consumption following common outpatient orthopedic surgeries, to generate prescribing guidelines to optimize opioid prescribing, and to understand the effect of pre-operative opioid counseling on opioid consumption following these procedures.
This is a prospective randomized controlled study that will involve eight fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery). Consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). The control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative counseling.
Basic demographic and surgical data will be collected. Primary outcomes will be assessed at the post-operative visit. These include the total number of opioid pills consumed, average daily pain scores, and adverse effects. Secondary outcomes include the number of days the medication was used, medication refill requests, and patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid counseling group
Arm Type
Experimental
Arm Description
Counseling provided to patients prior to surgery regarding opioid usage, side effect, long term effect and risks of opioids.
Arm Title
No Counseling
Arm Type
No Intervention
Arm Description
No preoperative counseling will be provided to this group. Standard medication information will be provided only.
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative opioid counseling
Intervention Description
Patients will be randomized to receive counseling regarding opioid medication and post operative pain control.
Primary Outcome Measure Information:
Title
Post operative opioid consumption
Description
The primary outcome measure will be post operative opioid consumption.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients indicated to undergo outpatient orthopedic surgery in one of the four areas included in the study (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery).
Age eligibility is > 18 years of age.
Exclusion Criteria:
Inpatient procedures.
Pediatric patients (age < 18 years).
Known allergy to narcotic medication.
Pregnant female patients.
Non-English speaking patients
History of chronic pain and/or narcotic use preoperatively.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asif Ilyas
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid Consumption After Orthopaedic Surgery
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