Opioid Counseling in Pain Management

Pain, Postoperative Clinical Trial

Official title:

A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Reduction Mammoplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03985358
• Other study ID #: Pro00037881
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: June 2023

Study information

• Verified date: September 2021
• Source: University of South Florida
• Contact: Thanh Tran, MPH
• Phone: 8138448544
• Email: thanhtran[@]health.usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Johnson SP, Chung KC, Zhong L, Shauver MJ, Engelsbe MJ, Brummett C, Waljee JF. Risk of Prolonged Opioid Use Among Opioid-Naïve 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. — View 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. — View 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-publheal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	1 month
Primary	Opioid consumption	pain pill counts	1 month
Primary	Patient satisfaction	Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied	3 months