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OpenTrials
Completed

NCT Number: NCT04138264

Opioid Counseling Following Orthopaedic Surgery

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.

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of pills consumed

    Time frame: Up to 6 weeks

    Patients asked to keep daily diary which includes number of pills consumed during the post-operative period

Secondary outcomes

  1. Morphine equivalents (MEQ)

    Time frame: 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

  2. Visual Analog Scale (pain) Pain

    Time frame: Up to 6 weeks

    Pain as reported by patients on a daily basis via diaries

  3. Patient satisfaction with pain management: 5 point Likert Scale

    Time frame: Up to 6 weeks

    Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 24, 2019
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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