Opioid Consumption After Orthopaedic Surgery

Orthopedic Disorder Clinical Trial

Official title:

Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03173131
• Other study ID #: 17D.131
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 30, 2017
• Start date: June 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: May 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 280
• Est. completion date: October 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Orthopedic Disorder

Intervention

Behavioral:
• Pre-operative opioid counseling
Patients will be randomized to receive counseling regarding opioid medication and post operative pain control.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative opioid consumption	The primary outcome measure will be post operative opioid consumption.	3 months