Opioid Counseling Following Orthopaedic Surgery

Not Applicable

Completed

• Conditions: Orthopedic Disorder
• Interventions: Other: Preoperative opioid counseling

• Registration Number: NCT04138264
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-19
• Primary Completion: 2018-11-02
• Study Completion: 2019-05-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Study First Posted: 2019-10-24
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery

Exclusion Criteria

• male of female less than 18 years old
• patients schedule to undergo inpatient procedures
• patients undergoing surgeries distal to the wrist
• patients undergoing surgeries under local anesthesia only

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peroperative counseling	Preoperative opioid counseling	-

Primary Outcome Measures

Name	Time	Method
Number of pills consumed	Up to 6 weeks	Patients asked to keep daily diary which includes number of pills consumed during the post-operative period

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with pain management: 5 point Likert Scale	Up to 6 weeks	Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale
Morphine equivalents (MEQ)	Up to 6 weeks	MEQs is a standardized method of comparing different types of pain medication with a gold-standard. All pain medication can be converted to MEQs
Visual Analog Scale (pain) Pain	Up to 6 weeks	Pain as reported by patients on a daily basis via diaries

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States