Recruiting

Dexamethasone

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07556952

Conditions

Post-Mastectomy Chronic Pain Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone (intravenous)

Normal Saline (0.9% NaCl)

Study Details

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

Study ID

NCT07556952

Start date

Apr 13, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Normal Saline (0.9% NaCl)

normal saline at a equivalent volume

Primary outcome measure

  • Chronic post-mastectomy pain [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Oana Predescu, MD, PhD, MSc

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

Anne-Françoise Rousseau, MD, PhD

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

Locations

McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada

Contacts

Oana Predescu, MD, PhD, MSc

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

Anne-Françoise Rousseau, MD, PhD

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

Principal Investigator:

Oana Predescu, MD, PhD, MSc

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jun 4, 2026

Last verified

Apr, 2026

Keywords

  • dexamethasone
  • mastectomy
  • chronic pain
  • post-operative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-06-04.