Opioid Counseling in Pain Management

NCT03985358 | Unknown

• 1 other identifier: Pro00037881
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

opioid counseling; bilateral reduction mammoplasty

Outcome Measures

Primary Outcomes (3)

• 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

• Opioid consumption

  pain pill counts

  1 month

• Patient satisfaction

  Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied

  3 months

Study Arms (2)

Control Group

NO INTERVENTION

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.

Treatment Group

EXPERIMENTAL

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

Interventions

Opioid counseling plus standard of care instructions OTHER

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (6)

• 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.

  PMID: 27869630 BACKGROUND

• 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.

  PMID: 26510070 BACKGROUND

• 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.

  PMID: 24667804 BACKGROUND

• 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.

  PMID: 28890331 RESULT

• 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.

  PMID: 25581144 RESULT

• 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.

  PMID: 27692801 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wilton Triggs, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh Tran, MPH

CONTACT

8138448544; thanhtran@health.usf.edu

Kristina Bolling, MPH

CONTACT

8138448061; kristina16@health.usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: June 13, 2019
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)