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Opioid Counseling Following Orthopaedic Surgery

Primary Purpose

Orthopedic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative opioid counseling
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Peroperative counseling

No preoperative counseling

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Visual Analog Scale (pain) Pain
Pain as reported by patients on a daily basis via diaries
Patient satisfaction with pain management: 5 point Likert Scale
Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale

Full Information

First Posted
October 21, 2019
Last Updated
October 23, 2019
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04138264
Brief Title
Opioid Counseling Following Orthopaedic Surgery
Official Title
Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peroperative counseling
Arm Type
Active Comparator
Arm Title
No preoperative counseling
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Preoperative opioid counseling
Intervention Description
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 Outcome Measure Information:
Title
Number of pills consumed
Description
Patients asked to keep daily diary which includes number of pills consumed during the post-operative period
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Morphine equivalents (MEQ)
Description
MEQs is a standardized method of comparing different types of pain medication with a gold-standard. All pain medication can be converted to MEQs
Time Frame
Up to 6 weeks
Title
Visual Analog Scale (pain) Pain
Description
Pain as reported by patients on a daily basis via diaries
Time Frame
Up to 6 weeks
Title
Patient satisfaction with pain management: 5 point Likert Scale
Description
Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

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Opioid Counseling Following Orthopaedic Surgery

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