Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioid Counseling in Pain Management

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03985358
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Other: Opioid counseling plus standard of care instructions Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Reduction Mammoplasty
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
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.
Experimental: Treatment Group
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).
Other: Opioid counseling plus standard of care instructions
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 Measures :
  1. Pain level [ Time Frame: 1 month ]
    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"

  2. Opioid consumption [ Time Frame: 1 month ]
    pain pill counts

  3. Patient satisfaction [ Time Frame: 3 months ]
    Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03985358


Contacts
Layout table for location contacts
Contact: Thanh Tran, MPH 8138448544 thanhtran@health.usf.edu
Contact: Kristina Bolling, MPH 8138448061 kristina16@health.usf.edu

Locations
Layout table for location information
United States, Florida
Tampa General Hospital Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Thanh Tran, MPH    813-844-8544    thanhtran@health.usf.edu   
Contact: Kristina Bolling, MPH    813-844-8061    kristina16@health.usf.edu   
Principal Investigator: Wilton Triggs, MD         
Sub-Investigator: David Smith, MD         
Sponsors and Collaborators
University of South Florida
Investigators
Layout table for investigator information
Principal Investigator: Wilton Triggs, MD University of South Florida

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03985358     History of Changes
Other Study ID Numbers: Pro00037881
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of South Florida:
opioid counseling
bilateral reduction mammoplasty

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents