PainNCT04558840
Enhanced Recovery After Bilateral Reduction Mammaplasty
A study testing Macromastia in people with Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Macromastia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 30 Nov 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting
- Age 18 and older
- BMI less than 40, non-smokers.
Who cannot join
- age less than 18,
- BMI over 40,
- smokers,
- uncontrolled diabetes,
- American Society of Anesthesiologists (ASA) status scores 3 or higher
- patients with allergies to any of the medications in the ERAS or current practice regiments (gabapentin, celecoxib, ketorolac, ondansetron, or hydrocodone).
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- History of narcotic or IV drug abuse
- History of chronic pain
- Hypersensitivity or allergy to any of these drugs: gabapentin, celecoxib, ketorolac, hydrocodone, ibuprofen or acetaminophen
- Current pregnancy or planning pregnancy in the next xx weeks/ months
- Contraindications to NSAID drugs (ketorolac, ibuprofen, celecoxib): coagulation disorder, active bleeding, severe renal impairment, hepatic impairment.
- Contraindications to gabapentin: caution for CrCl <60, caution in elderly, caution if alcohol consumption
- Contraindications to acetaminophen: hepatic or renal impairment, chronic alcohol use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
This single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting.
Read the detailed description
This is a non-blinded, non-inferiority, randomized control trial with the primary outcome of interest being overall pain, with secondary outcomes including adverse effects from pain medications, patient satisfaction with their pain regiment and with their surgery, and the impact of pain on their daily activities. This study is designed to follow one-hundred (100) qualified and consenting patients seeing the PI/surgeon (JMK) at his office at UT Southwestern for their initial operative consultation for macromastia. If patients meet eligibility criteria, they will be offered enrollment in the trial.
- Conditions
- Pain
- Being tested
- Macromastia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacromastiaProcedure or surgery
Also called Mammaplasty
Patients with macromastia seeing the principle investigator (PI) (JMK) at his office at the Outpatient Building, which includes the Outpatient Surgery Center (OSC), in the Department of Plastic Surgery clinic at UT-Southwestern for their initial operative consultation for reduction mammaplasty will be offered enrollment in the trial if they are deemed appropriate surgical candidates, based on the PI's clinical judgement and expertise.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) Arm | Active comparator | ERAS Arm will undergo multimodal regiment:
Before Surgery- gabepentin 300mg and celecoxib 400mg once the day before surgery and again 3 hours prior to surgery.
During surgery- subjects will receive ketorolac 30mg IV ketorolac once (15mg for patients age 64 years and above).
Post-operatively- Gabapentin 100mg three times daily for POD0-7, ketorolac 10mg four times daily for POD1-5 days, and ondansetron 4mg as needed for nausea; patients will also have a prescription for hydrocodone-acetaminophen 5/325mg tabs that they may fill if needed for emergency/breakthrough pain. Receives: Procedure: Macromastia |
| Current Practice Arm | Active comparator | The current practice arm will include: post-operatively, hydrocodone-acetaminophen 5/325mg tabs and ibuprofen 800mg, as needed for pain. Additionally, acetaminophen may be used in conjunction with the above regiment. Ibuprofen and acetaminophen can be taken as needed or alternating every 6 hours, scheduled. Receives: Procedure: Macromastia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Questionnaire
Determine the efficacy of non-narcotic pain regiments in patients undergoing breast reduction surgery and compare it to narcotic-based pain regiments in improving post-operative pain in patients undergoing breast reduction surgery.
Patients will be asked to rate their pain from a scale of 0 ("No Pain") to 10 ("Pain as bad as you can imagine").
Measured: Day 0 - Day 7
Secondary outcomes (3)
Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome
The following questionnaires will be used to track the patients satisfaction following their procedure: BREAST-Q Postoperative Reduction Module Satisfaction with Outcome.
Patients will be asked to rate their satisfaction with: Very dissatisfied, Somewhat dissatisfied, Somewhat satisfied or very satisfied.
Measured: Day 0- Day 7
Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey
The following questionnaires will be used to track the patients satisfaction following their procedure: BREAST- Q Postoperative Reconstruction Module Satisfaction with Information Survey.
Patients will be asked to rate their satisfaction with: Very dissatisfied, Somewhat dissatisfied, Somewhat satisfied or very satisfied.
Measured: Day 0- Day 7
Post operative Quality of Life Questionnaire
The following questionnaires will be used to track the patients satisfaction following their procedure.
The postoperative questions do not have an applicable scale.
Measured: Day 0- Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start15 Oct 2021
- Primary completion9 May 2023
- Study completion30 Nov 2023
Why it stopped: interim analysis completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey M. Kenkel, University of Texas Southwestern Medical Center
- Investigators
- Jeffrey Kenkel, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558840
- Sponsor's protocol ID
- STU 2020-0813
- Status last verified
- Dec 2023
- First submitted
- 2 Sep 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Bilateral Reduction Mammaplasty
- ClinicalTrials.gov ID
- NCT04558840
- Acronym / sponsor ID
- STU 2020-0813
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 22 Sep 2020 (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.
This single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting.
Detailed description
This is a non-blinded, non-inferiority, randomized control trial with the primary outcome of interest being overall pain, with secondary outcomes including adverse effects from pain medications, patient satisfaction with their pain regiment and with their surgery, and the impact of pain on their daily activities. This study is designed to follow one-hundred (100) qualified and consenting patients seeing the PI/surgeon (JMK) at his office at UT Southwestern for their initial operative consultation for macromastia. If patients meet eligibility criteria, they will be offered enrollment in the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) Arm | Active comparator | Procedure: MacromastiaERAS Arm will undergo multimodal regiment: Before Surgery- gabepentin 300mg and celecoxib 400mg once the day before surgery and again 3 hours prior to surgery. During surgery- subjects will receive ketorolac 30mg IV ketorolac once (15mg for patients age 64 years and above). Post-operatively- Gabapentin 100mg three times daily for POD0-7, ketorolac 10mg four times daily for POD1-5 days, and ondansetron 4mg as needed for nausea; patients will also have a prescription for hydrocodone-acetaminophen 5/325mg tabs that they may fill if needed for emergency/breakthrough pain. |
| Current Practice Arm | Active comparator | Procedure: MacromastiaThe current practice arm will include: post-operatively, hydrocodone-acetaminophen 5/325mg tabs and ibuprofen 800mg, as needed for pain. Additionally, acetaminophen may be used in conjunction with the above regiment. Ibuprofen and acetaminophen can be taken as needed or alternating every 6 hours, scheduled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting
- Age 18 and older
- BMI less than 40, non-smokers.
Key exclusion criteria (13 listed)
- age less than 18,
- BMI over 40,
- smokers,
- uncontrolled diabetes,
- American Society of Anesthesiologists (ASA) status scores 3 or higher
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 |
|---|---|---|
| MacromastiaAlso: MammaplastyPatients with macromastia seeing the principle investigator (PI) (JMK) at his office at the Outpatient Building, which includes the Outpatient Surgery Center (OSC), in the Department of Plastic Surgery clinic at UT-Southwestern for their initial operative consultation for reduction mammaplasty will be offered enrollment in the trial if they are deemed appropriate surgical candidates, based on the PI's clinical judgement and expertise. | Procedure or surgery | Current Practice Arm, Enhanced Recovery After Surgery (ERAS) Arm |
Primary outcome
Post-operative Pain Questionnaire
Time frame: Day 0 - Day 7
Determine the efficacy of non-narcotic pain regiments in patients undergoing breast reduction surgery and compare it to narcotic-based pain regiments in improving post-operative pain in patients undergoing breast reduction surgery. Patients will be asked to rate their pain from a scale of 0 ("No Pain") to 10 ("Pain as bad as you can imagine").
3 secondary outcomes
Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome
Time frame: Day 0- Day 7
Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey
Time frame: Day 0- Day 7
Post operative Quality of Life Questionnaire
Time frame: Day 0- Day 7
Results and safety
The study was stopped early (reason given: interim analysis completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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.
Jeffrey Kenkel principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macromastia in people with Pain, run by University of Texas Southwestern Medical Center 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Dec 2023. 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?
The study was stopped early (reason given: interim analysis completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Questionnaire (time frame: Day 0 - Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.