Pain, PostoperativeNCT03985358
Opioid Counseling in Pain Management
A study of Pain, Postoperative, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tampa General Hospital
Tampa, Florida, 33606
Thanh Tran, MPH, 813-844-8544, thanhtran@health.usf.edu
Kristina Bolling, MPH, 813-844-8061, kristina16@health.usf.edu
About this study
Official title: A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Reduction Mammoplasty
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Opioid counseling plus standard of care instructions
- Keywords
- opioid counseling, bilateral reduction mammoplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid counseling plus standard of care instructionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Opioid counseling plus standard of care instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 1 month
Opioid consumption
pain pill counts
Measured: 1 month
Patient satisfaction
Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilton Triggs, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985358
- Sponsor's protocol ID
- Pro00037881
- Status last verified
- Sep 2021
- First submitted
- 25 Oct 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27869630Costello 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.
PubMed 26510070Holman 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.
PubMed 24667804Alter 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.
PubMed 28890331Kolodny 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.
PubMed 25581144Johnson 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.
PubMed 27692801
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Reduction Mammoplasty
- ClinicalTrials.gov ID
- NCT03985358
- Acronym / sponsor ID
- Pro00037881
- Conditions
- Pain, Postoperative
- Keywords
- opioid counseling, bilateral reduction mammoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Opioid counseling plus standard of care instructionsPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid counseling plus standard of care instructionsSame 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 | Other | Treatment Group |
Primary outcome
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"
Opioid consumption
Time frame: 1 month
pain pill counts
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 27869630Kim 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.
- Background: PubMed 26510070Costello 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.
- Background: PubMed 24667804Holman 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 publication: PubMed 28890331Alter 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 publication: PubMed 25581144Kolodny 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 publication: PubMed 27692801Johnson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilton Triggs, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pain, Postoperative, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanh Tran, MPH (8138448544, thanhtran@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985358, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.