Clinical trial NCT03173131: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Post operative opioid consumption
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Asif Ilyas
role: PRINCIPAL_INVESTIGATOR
References: