Dex & Mastectomy Pain

NCT07556952 | Recruiting Phase 4

• 1 other identifier: 2026-11692
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Mastectomy Chronic Pain Syndrome

Keywords

dexamethasone; mastectomy; chronic pain; post-operative

Outcome Measures

Primary Outcomes (1)

• Chronic post-mastectomy pain

  Brief Pain Inventory score ≥3/10

  3 months postoperatively

Secondary Outcomes (14)

• Acute postoperative pain

  within 0-15 minutes after post-anesthesia care unit (PACU) admission

• acute postoperative pain

  Within 30 minutes prior to PACU discharge

• Acute postoperative pain

  on postoperative day 1

• Acute postoperative pain

  on postoperative day 7

• Acute postoperative pain

  1 month postoperatively

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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)

Interventions

Dexamethasone (intravenous) DRUG

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.

Dexamethasone

Normal Saline (0.9% NaCl) DRUG

normal saline at a equivalent volume

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: This study is focusing on mastectomy for breast cancer in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oana Predescu, MD, PhD, MSc

CONTACT

514-934-1934; oana.predescu@mcgill.ca

Anne-Françoise Rousseau, MD, PhD

CONTACT

514-934-1934; anne-francoise.rousseau@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CA (1)