Post-Mastectomy Chronic Pain Syndrome
Conditions
Keywords
dexamethasone, mastectomy, chronic pain, post-operative
Brief summary
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.
Interventions
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
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic post-mastectomy pain | 3 months postoperatively | Brief Pain Inventory score ≥3/10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute postoperative pain | within 0-15 minutes after post-anesthesia care unit (PACU) admission | Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain) |
| acute postoperative pain | Within 30 minutes prior to PACU discharge | Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain) |
| postoperative nausea and vomiting | within 30 minutes prior to PACU discharge | binary question |
| postoperative complications | 3 months postoperatively | anamnesis |
| anxiety and depression | 3 months postoperatively | 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. |
| Analgesics consumption | Within 30 minutes prior to PACU discharge | The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the PACU stay |
| analgesics consumption | 3 months postoperatively | The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the second and third months after surgery |
| Postoperative complications | 3 months postoperatively | Any complication in relationship with the surgery occurring during the 3 months after surgery |
Countries
Canada
Contacts
McGill University Health Centre/Research Institute of the McGill University Health Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre