Opioid Counseling Following Orthopaedic Surgery

NCT ID: NCT04138264

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2019-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Peroperative counseling

Group Type: ACTIVE_COMPARATOR

Preoperative opioid counseling

Intervention Type: 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.

No preoperative counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

Ilyas2019

Identifier Type: -

Identifier Source: org_study_id