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Opioid Counseling Following Orthopaedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138264
Recruitment Status : Completed
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Orthopedic Disorder Other: Preoperative opioid counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : May 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Peroperative counseling 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.
No Intervention: No preoperative counseling


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138264


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04138264    
Other Study ID Numbers: Ilyas2019
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents