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Opioid Counseling in Pain Management

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid counseling plus standard of care instructions
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring opioid counseling, bilateral reduction mammoplasty

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Elective bilateral reduction mammoplasty to be performed as outpatient
  • Able and willing to provide informed consent
  • Able and willing to comply with study procedures

Exclusion Criteria:

  • Age < 18 years
  • Bilateral reduction mammoplasty planned/performed with any concomitant procedures
  • History of preoperative opioid consumption or rehabilitation
  • Opioid allergy
  • Local anesthetic given during or after procedure
  • Unable and/or unwilling to provide informed consent
  • Unable and/or unwilling to comply with study procedures

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

Patients randomized to the Control Group will not receive opioid counseling and will only receive their standard of care instructions for preoperative and postoperative care.

Patients randomized to the Treatment Group will have opioid counseling plus standard of care instructions given by the same counselor (investigator on the study) using the same counseling script at the randomization visit as well as at the visit where they come in for pre-admission testing prior to surgery (as a refresher).

Outcomes

Primary Outcome Measures

Pain level
using standard pain scale scores recorded in daily diary - using scale 0 to 10 with 0 being "no pain" and 10 being "worst pain imaginable"
Opioid consumption
pain pill counts
Patient satisfaction
Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied

Secondary Outcome Measures

Full Information

First Posted
October 25, 2018
Last Updated
September 28, 2021
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03985358
Brief Title
Opioid Counseling in Pain Management
Official Title
A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Reduction Mammoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.
Detailed Description
Prescription opioid abuse has been increasing dramatically in recent years. There is growing concern regarding the unprecedented increase in morbidity and mortality related to the use of opioids.1-2 In 2010 the rates of opioid sales, deaths, as well as associated treatment admissions have increased to more than triple the rates in 1999.1-2 Although policy makers and the media often associate the opioid crisis as a problem of nonmedical opioid abuse, evidence has suggested that opioid addiction occurs in both medical and nonmedical users.2 The Centers for Disease control and Prevention reported and warned that long-term opioid use often starts with treatment of some type of acute pain.3 Prescription opioids have been shown to be favorable in perioperative pain management, however, their effectiveness in chronic pain management is not as clear. Surgeons are among the highest opioid prescribers. Many common elective as well as trauma-related procedures have been reported as possible causes of increased prolonged opioid usage. Recent evidence also suggested that a considerable number of patients who were prescribed opioids struggle to with transitioning to non-opioid pain medications.1-6 Numerous methods have been considered and explored in effort of decreasing the misuse and abuse of prescription opioids. One of the methods being opioid counseling, in which patients are educated on the effects and risks of short-term and long-term opioid usage and physicians recommend and discuss the appropriate opioid usage as well as alternative nonopioid options. It has also been indicated that counseling is more effective if given earlier on in the patient's surgical care rather than through rushed education overview at discharge.1,4-6 Therefore, the purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
opioid counseling, bilateral reduction mammoplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients randomized to the Control Group will not receive opioid counseling and will only receive their standard of care instructions for preoperative and postoperative care.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Patients randomized to the Treatment Group will have opioid counseling plus standard of care instructions given by the same counselor (investigator on the study) using the same counseling script at the randomization visit as well as at the visit where they come in for pre-admission testing prior to surgery (as a refresher).
Intervention Type
Other
Intervention Name(s)
Opioid counseling plus standard of care instructions
Intervention Description
Same counselor (investigator on the study) will use the same counseling script at the randomization visit as well as at the visit where they come in for pre-admission testing prior to surgery (as a refresher) to counsel patients
Primary Outcome Measure Information:
Title
Pain level
Description
using standard pain scale scores recorded in daily diary - using scale 0 to 10 with 0 being "no pain" and 10 being "worst pain imaginable"
Time Frame
1 month
Title
Opioid consumption
Description
pain pill counts
Time Frame
1 month
Title
Patient satisfaction
Description
Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Elective bilateral reduction mammoplasty to be performed as outpatient Able and willing to provide informed consent Able and willing to comply with study procedures Exclusion Criteria: Age < 18 years Bilateral reduction mammoplasty planned/performed with any concomitant procedures History of preoperative opioid consumption or rehabilitation Opioid allergy Local anesthetic given during or after procedure Unable and/or unwilling to provide informed consent Unable and/or unwilling to comply with study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thanh Tran, MPH
Phone
8138448544
Email
thanhtran@health.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Bolling, MPH
Phone
8138448061
Email
kristina16@health.usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilton Triggs, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanh Tran, MPH
Phone
813-844-8544
Email
thanhtran@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Kristina Bolling, MPH
Phone
813-844-8061
Email
kristina16@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Wilton Triggs, MD
First Name & Middle Initial & Last Name & Degree
David Smith, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27869630
Citation
Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
Results Reference
background
PubMed Identifier
26510070
Citation
Costello M. Prescription Opioid Analgesics: Promoting Patient Safety with Better Patient Education. Am J Nurs. 2015 Nov;115(11):50-6. doi: 10.1097/01.NAJ.0000473315.02325.b4.
Results Reference
background
PubMed Identifier
24667804
Citation
Holman JE, Stoddard GJ, Horwitz DS, Higgins TF. The effect of preoperative counseling on duration of postoperative opiate use in orthopaedic trauma surgery: a surgeon-based comparative cohort study. J Orthop Trauma. 2014 Sep;28(9):502-6. doi: 10.1097/BOT.0000000000000085.
Results Reference
background
PubMed Identifier
28890331
Citation
Alter TH, Ilyas AM. A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery. J Hand Surg Am. 2017 Oct;42(10):810-815. doi: 10.1016/j.jhsa.2017.07.003. Epub 2017 Sep 8.
Results Reference
result
PubMed Identifier
25581144
Citation
Kolodny A, Courtwright DT, Hwang CS, Kreiner P, Eadie JL, Clark TW, Alexander GC. The prescription opioid and heroin crisis: a public health approach to an epidemic of addiction. Annu Rev Public Health. 2015 Mar 18;36:559-74. doi: 10.1146/annurev-publhealth-031914-122957. Epub 2015 Jan 12.
Results Reference
result
PubMed Identifier
27692801
Citation
Johnson SP, Chung KC, Zhong L, Shauver MJ, Engelsbe MJ, Brummett C, Waljee JF. Risk of Prolonged Opioid Use Among Opioid-Naive Patients Following Common Hand Surgery Procedures. J Hand Surg Am. 2016 Oct;41(10):947-957.e3. doi: 10.1016/j.jhsa.2016.07.113. Epub 2016 Sep 28.
Results Reference
result

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Opioid Counseling in Pain Management

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