Dexamethasone for Post Mastectomy Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Oana Predescu, MD, PhD, MSc
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Thomas Schricker, MD, PhD
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of dexamethasone 8 mg or placebo administered intravenously at induction of anesthesia
Follow-up
Participants are monitored for chronic post-mastectomy pain and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
Participants randomized to the control group will receive a placebo, consisting of an equivalent volume of normal saline, administered intravenously at induction of anesthesia.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
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