Opioid Consumption After Orthopaedic Surgery

NCT03173131 | Unknown

• 1 other identifier: 17D.131
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Post operative opioid consumption

  The primary outcome measure will be post operative opioid consumption.

  3 months

Study Arms (2)

Opioid counseling group

EXPERIMENTAL

Counseling provided to patients prior to surgery regarding opioid usage, side effect, long term effect and risks of opioids.

Behavioral: Pre-operative opioid counseling

No Counseling

NO INTERVENTION

No preoperative counseling will be provided to this group. Standard medication information will be provided only.

Interventions

Pre-operative opioid counseling BEHAVIORAL

Patients will be randomized to receive counseling regarding opioid medication and post operative pain control.

Opioid counseling group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Asif Ilyas

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: June 1, 2017
• Study Start: June 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)