Post-Mastectomy Chronic Pain Syndrome study: Dexamethasone vs Normal Saline
Official title Dex & Mastectomy Pain
ClinicalTrials.gov ID: NCT07556952
What this study is testing
What is Dexamethasone (intravenous)?
An investigational intravenous corticosteroid being studied for its potential to reduce post‑mastectomy chronic pain syndrome. It is designed to reduce inflammation and modulate immune responses.
Also referred to as Dexamethasone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The trial wants to find out if the steroid dexamethasone, given around the time of surgery, changes the chance of having chronic pain three months after a mastectomy.
- Who it's for
- It is looking for adult patients who are having a mastectomy and are at risk for long‑term pain.
- What's involved
- Participants will receive either dexamethasone or a placebo during surgery. After surgery they will be followed up and asked about pain and may have some routine check‑ups.
- Time commitment
- The study lasts about three months after surgery, with follow‑up visits to assess pain at that time.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female patients aged 18-75 years who can provide consent
- undergoing unilateral or bilateral mastectomy
- with or without lymph node dissection and/or immediate reconstruction,
- ASA physical status I-III.
You likely can't join if
- Male sex;
- pre-existing chronic pain conditions;
- chronic opioid use;
- pregnancy or breastfeeding;
- breast surgery within the last three years;
- chronic corticosteroid therapy;
See the full eligibility criteria
- Female patients aged 18-75 years who can provide consent
- undergoing unilateral or bilateral mastectomy
- with or without lymph node dissection and/or immediate reconstruction,
- ASA physical status I-III.
- Male sex;
- pre-existing chronic pain conditions;
- chronic opioid use;
- pregnancy or breastfeeding;
- breast surgery within the last three years;
- chronic corticosteroid therapy;
- contraindications to dexamethasone.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.