Dex & Mastectomy Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone (intravenous), Normal Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Post-Mastectomy Chronic Pain Syndrome. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled Trial
Overview
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
- Drug Dexamethasone (intravenous)
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. - Drug Normal Saline (0.9% NaCl)
normal saline at a equivalent volume
Primary outcome measures
- Chronic post-mastectomy pain [Time frame: 3 months postoperatively]
Secondary outcome measures (12)
- Acute postoperative pain [Time frame: within 0-15 minutes after post-anesthesia care unit (PACU) admission]
- acute postoperative pain [Time frame: Within 30 minutes prior to PACU discharge]
- Acute postoperative pain [Time frame: on postoperative day 1]
- Acute postoperative pain [Time frame: on postoperative day 7]
- Acute postoperative pain [Time frame: 1 month postoperatively]
- Acute postoperative pain [Time frame: Within 30 minutes prior to PACU discharge]
- Acute postoperative pain [Time frame: on postoperative day 1]
- Acute postoperative pain [Time frame: on postoperative day 7]
- Acute postoperative pain [Time frame: 1 month postoperatively]
- postoperative nausea and vomiting [Time frame: within 30 minutes prior to PACU discharge]
- postoperative nausea and vomiting [Time frame: on postoperative day 1]
- postoperative nausea and vomiting [Time frame: on postoperative day 7]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- McGill University Health Centre (MUHC) — Montreal
Identifiers
NCT: NCT07556952 · 2026-11692