Opioid Counseling Following 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: Completed

Administrative data

• NCT number: NCT04138264
• Other study ID #: Ilyas2019
• Status: Completed
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: October 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: May 1, 2019
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Other:
• Preoperative opioid counseling
preoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed.

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pills consumed	Patients asked to keep daily diary which includes number of pills consumed during the post-operative period	Up to 6 weeks
Secondary	Morphine equivalents (MEQ)	MEQs is a standardized method of comparing different types of pain medication with a gold-standard. All pain medication can be converted to MEQs	Up to 6 weeks
Secondary	Visual Analog Scale (pain) Pain	Pain as reported by patients on a daily basis via diaries	Up to 6 weeks
Secondary	Patient satisfaction with pain management: 5 point Likert Scale	Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale	Up to 6 weeks