Dexamethasone for post-mastectomy chronic pain
Official title: Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled Trial
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT07556952 · Data updated 2026-11-12
This trial will test whether giving dexamethasone during mastectomy lessens long-term post-mastectomy chronic pain in adult women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 170 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07556952 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–75 who can consent and are scheduled for unilateral or bilateral mastectomy (with or without lymph node dissection or immediate reconstruction) and have ASA physical status I–III are ideal candidates.
✕Probably not a fit
Men, patients with pre-existing chronic pain, chronic opioid or corticosteroid use, recent breast surgery, pregnancy/breastfeeding, or contraindications to dexamethasone are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional study enrolls adult women (18–75) undergoing unilateral or bilateral mastectomy at the McGill University Health Centre. Participants are assigned to receive a perioperative intravenous dose of dexamethasone or an intravenous normal saline comparator and are followed for pain outcomes after the expected healing period. The protocol excludes patients with pre-existing chronic pain, chronic corticosteroid or opioid use, recent breast surgery, pregnancy or breastfeeding, and those with contraindications to dexamethasone. Outcomes focus on the presence and severity of chronic post-mastectomy pain and its impact on function and quality of life.
Why it matters
Potential benefit: If successful, perioperative dexamethasone could reduce the incidence or severity of chronic pain after mastectomy and improve patients' long-term function and quality of life.
How similar studies have gone: Observational studies have suggested a link between perioperative dexamethasone and altered post-surgical pain outcomes, but randomized data specifically addressing chronic post-mastectomy pain are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where it's running
-
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Oana Predescu, MD, PhD, MSc — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Oana Predescu, MD, PhD, MSc
- Email: oana.predescu@mcgill.ca
- Phone: 514-934-1934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.