Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty (NCT04919317) | Clinical Trial Compass
CompletedPhase 2
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
United States56 participantsStarted 2017-09-29
Plain-language summary
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Age 18-80
* Bilateral reduction mammaplasty
* American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
* Must choose to receive preoperative nerve block as part of pain management strategy
Exclusion Criteria:
* Allergy to dexamethasone or bupivacaine
* History of postoperative nausea and vomiting following anesthesia
* History of chronic pain conditions
* History of narcotic abuse or dependency
* History of chronic renal disease
* History of chronic liver disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Initial Visual Analog Scale (VAS) Pain Scores
Timeframe: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
2
4-hour Visual Analog Scale (VAS) Pain Scores
Timeframe: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
3
8-hour Visual Analog Scale (VAS) Pain Scores
Timeframe: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
4
12-hour Visual Analog Scale (VAS) Pain Scores
Timeframe: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
5
16-hour Visual Analog Scale (VAS) Pain Scores
Timeframe: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
6
20-hour Visual Analog Scale (VAS) Pain Scores
Timeframe: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)