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Dex & Mastectomy Pain

RecruitingPhase 4NCT07556952
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

Chronic post-surgical pain is a common complication following mastectomy and represents a significant source of long-term morbidity. Pain that persists beyond the expected period of tissue healing can interfere with physical functioning, psychological well-being, and quality of life. Despite advances in surgical and anesthetic techniques, the mechanisms contributing to chronic postmastectomy pain remain incompletely understood. Dexamethasone is a corticosteroid routinely administered in the perioperative setting for the prevention of postoperative nausea and vomiting. In addition to its antiemetic properties, dexamethasone has potent anti-inflammatory and immunomodulatory effects that may influence tissue healing and pain processing pathways. Given its widespread use during surgery, understanding its potential impact on long-term pain outcomes is clinically relevant. Clinical observational studies examining the association between perioperative dexamethasone administration and chronic postmastectomy pain have not demonstrated a clear or consistent relationship. However, by design, observational studies cannot establish causality or definitively exclude a potential effect of perioperative dexamethasone on the development of chronic post-surgical pain. In contrast, preclinical studies using animal models of post-surgical pain have shown that perioperative exposure to dexamethasone may be associated with increased postoperative pain sensitivity and hyperalgesia. These findings suggest a potential biological mechanism through which perioperative corticosteroid administration could influence long-term pain outcomes, although their relevance to human surgical populations remains uncertain. To date, no randomized controlled trials have directly evaluated whether perioperative dexamethasone administration affects the incidence of chronic postmastectomy pain in humans. Given the routine use of dexamethasone in perioperative care, the absence of definitive clinical evidence, …

Study details

Official title
Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled Trial
Conditions
  • Post-Mastectomy Chronic Pain Syndrome
Interventions
  • Drug: Dexamethasone (intravenous)
  • Drug: Normal Saline (0.9% NaCl)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Start date
2026-04-13
Primary completion
2028-03-31
Sex
Female
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Canadian sites (1)

FacilityCityProvince
McGill University Health Centre (MUHC)MontrealQuebec

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07556952