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Opioid Consumption After Orthopaedic Surgery

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Thomas Jefferson University

Status

Unknown

Conditions

Orthopedic Disorder

Treatments

Behavioral: Pre-operative opioid counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT03173131
17D.131

Details and patient eligibility

About

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.

Full 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.

Enrollment

280 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

280 participants in 2 patient groups

Opioid counseling group
Experimental group
Description:
Counseling provided to patients prior to surgery regarding opioid usage, side effect, long term effect and risks of opioids.
Treatment:
Behavioral: Pre-operative opioid counseling
No Counseling
No Intervention group
Description:
No preoperative counseling will be provided to this group. Standard medication information will be provided only.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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