Opioid Counseling Following Orthopaedic Surgery

NCT04138264 | Completed

• 1 other identifier: Ilyas2019
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Morphine equivalents (MEQ)

  Up to 6 weeks

• Visual Analog Scale (pain) Pain

  Up to 6 weeks

• Patient satisfaction with pain management: 5 point Likert Scale

  Up to 6 weeks

Study Arms (2)

Peroperative counseling

ACTIVE COMPARATOR

Other: Preoperative opioid counseling

No preoperative counseling

NO INTERVENTION

Interventions

Preoperative opioid counseling OTHER

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.

Peroperative counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: June 19, 2018
• Primary Completion: November 2, 2018
• Study Completion: May 1, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

US (1)