Dex & Mastectomy Pain

Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Post-Mastectomy Chronic Pain Syndrome
• Intervention / Treatment: Drug: Dexamethasone (intravenous); Drug: Normal Saline (0.9% NaCl)

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Oana Predescu, MD, PhD, MSc; Phone Number: 44604 514-934-1934; Email: oana.predescu@mcgill.ca
• Study Contact Backup: Name: Anne-Françoise Rousseau, MD, PhD; Phone Number: 514-934-1934; Email: anne-francoise.rousseau@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • McGill University Health Centre (MUHC)
      • Contact: Oana Predescu, MD, PhD, MSc; Phone Number: 44604 514-934-1934; Email: oana.predescu@mcgill.ca
      • Contact: Anne-Françoise Rousseau, MD, PhD; Phone Number: 514-934-1934; Email: anne-francoise.rousseau@mcgill.ca
      • Principal Investigator: Oana Predescu, MD, PhD, MSc
      • Principal Investigator: Thomas Schricker, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; 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); 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.
Placebo Comparator: Placebo; 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); normal saline at a equivalent volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic post-mastectomy pain	Brief Pain Inventory score ≥3/10	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute postoperative pain	Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)	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)	Within 30 minutes prior to PACU discharge
Acute postoperative pain	Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)	on postoperative day 1
Acute postoperative pain	Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)	on postoperative day 7
Acute postoperative pain	Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)	1 month postoperatively
Acute postoperative pain	postoperative opioids consumption	Within 30 minutes prior to PACU discharge
Acute postoperative pain	postoperative opioids consumption	on postoperative day 1
Acute postoperative pain	postoperative opioids consumption	on postoperative day 7
Acute postoperative pain	postoperative opioids consumption	1 month postoperatively
postoperative nausea and vomiting	binary question	within 30 minutes prior to PACU discharge
postoperative nausea and vomiting	binary question	on postoperative day 1
postoperative nausea and vomiting	binary question	on postoperative day 7
postoperative complications	anamnesis	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.	3 months postoperatively

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Oana Predescu, MD, PhD, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Thomas Schricker, MD, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; dexamethasone; mastectomy; post-operative
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Pharmaceutical Preparations; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pregnadienetriols; Dexamethasone; Saline Solution
• Other Study ID Numbers: 2026-11692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No