A Phase 4 interventional study of Dexamethasone (intravenous) and Normal Saline (0.9% NaCl) in Post-Mastectomy Chronic Pain Syndrome, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Prevention
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, and the presence of preclinical signals suggesting a possible effect on pain sensitization, a randomized, double-blind, placebo-controlled trial is warranted.
This study focuses on adult patients undergoing mastectomy, a population with a well-established risk of chronic post-surgical pain. Chronic pain will be assessed three months after surgery, a commonly accepted time point for distinguishing chronic post-surgical pain from normal postoperative recovery. The proposed study design aims to minimize bias and generate high-quality evidence to inform perioperative medication practices.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 170 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
Participants randomized to the intervention group will receive a single dose of dexamethasone 8 mg administered intravenously at induction of anesthesia. This dose and timing reflect standard clinical practice for patients at risk of postoperative nausea and vomiting.
Drug: Dexamethasone (intravenous)
Participants randomized to the control group will receive a placebo, consisting of an equivalent volume of normal saline, administered intravenously at induction of anesthesia.
Drug: Normal Saline (0.9% NaCl)
The investigational product used in this study is dexamethasone, a corticosteroid routinely administered in the perioperative setting for the prevention of postoperative nausea and vomiting.
normal saline at a equivalent volume
Chronic post-mastectomy pain
Brief Pain Inventory score ≥3/10
Time frame: 3 months postoperatively
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Time frame: within 0-15 minutes after post-anesthesia care unit (PACU) admission
acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Time frame: Within 30 minutes prior to PACU discharge
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Time frame: on postoperative day 1
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Time frame: on postoperative day 7
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Time frame: 1 month postoperatively
Acute postoperative pain
postoperative opioids consumption
Time frame: Within 30 minutes prior to PACU discharge
Acute postoperative pain
postoperative opioids consumption
Time frame: on postoperative day 1
Acute postoperative pain
postoperative opioids consumption
Time frame: on postoperative day 7
Acute postoperative pain
postoperative opioids consumption
Time frame: 1 month postoperatively
postoperative nausea and vomiting
binary question
Time frame: within 30 minutes prior to PACU discharge
postoperative nausea and vomiting
binary question
Time frame: on postoperative day 1
postoperative nausea and vomiting
binary question
Time frame: on postoperative day 7
postoperative complications
anamnesis
Time frame: 3 months postoperatively
anxiety and depression
Hospital Anxiety and Depression Scale (HADS): It consists of 14 questions, with 7 measuring anxiety (HADS-A) and 7 measuring depression (HADS-D). Scoring: Each question is scored from 0-3, totaling 0-21 per subscale. A score from 0 to 7 is within the typical range, a score between 8 and 10 is a borderline score, and a score \>10 depicts a moderate to severe anxiety or depression.
Time frame: 3 months postoperatively
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the PACU stay
Time frame: Within 30 minutes prior to PACU discharge
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the first 24h after surgery
Time frame: on postoperative day 1
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the week after surgery
Time frame: on postoperative day 7
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the month after surgery
Time frame: 1 month postoperatively
analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the second and third months after surgery
Time frame: 3 months postoperatively
Postoperative complications
Any complication in relationship with the surgery occurring during the 3 months after surgery
Time frame: 3 months postoperatively
Functional recovery
New or worsening cognitive, physical, sleeping disorders occurring during the 3 months after surgery, using binary question
Time frame: 1 month postoperatively
Functional recovery
New or worsening cognitive, physical, sleeping disorders occurring during the 3 months after surgery, using binary question
Time frame: 3 months postoperatively
Health-related quality of life
Health-related quality of life, assessed using a numeric rating scale
Time frame: 1 month postoperatively
Health-related quality of life
Health-related quality of life, assessed using a numeric rating scale
Time frame: 3 months postoperatively
Plan to share: Undecided
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McGill University Health Centre/Research Institute of the McGill University Health Centre