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NCT Number: NCT07556952

Dex & Mastectomy Pain

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Location status: Recruiting

Location contact

Anne-Françoise Rousseau, MD, PhD

CONTACT

[email protected]

514-934-1934

Oana Predescu, MD, PhD, MSc

CONTACT

[email protected]

514-934-1934 ext. 44604

Oana Predescu, MD, PhD, MSc

PRINCIPAL_INVESTIGATOR

Thomas Schricker, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Normal Saline (0.9% NaCl)

Drug

normal saline at a equivalent volume

Primary outcomes

  1. Chronic post-mastectomy pain

    Time frame: 3 months postoperatively

    Brief Pain Inventory score ≥3/10

Secondary outcomes

  1. Acute postoperative pain

    Time frame: 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)

  2. acute postoperative pain

    Time frame: Within 30 minutes prior to PACU discharge

    Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)

  3. Acute postoperative pain

    Time frame: on postoperative day 1

    Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)

  4. Acute postoperative pain

    Time frame: on postoperative day 7

    Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)

  5. Acute postoperative pain

    Time frame: 1 month postoperatively

    Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)

  6. Acute postoperative pain

    Time frame: Within 30 minutes prior to PACU discharge

    postoperative opioids consumption

  7. Acute postoperative pain

    Time frame: on postoperative day 1

    postoperative opioids consumption

  8. Acute postoperative pain

    Time frame: on postoperative day 7

    postoperative opioids consumption

  9. Acute postoperative pain

    Time frame: 1 month postoperatively

    postoperative opioids consumption

  10. postoperative nausea and vomiting

    Time frame: within 30 minutes prior to PACU discharge

    binary question

  11. postoperative nausea and vomiting

    Time frame: on postoperative day 1

    binary question

  12. postoperative nausea and vomiting

    Time frame: on postoperative day 7

    binary question

  13. postoperative complications

    Time frame: 3 months postoperatively

    anamnesis

  14. anxiety and depression

    Time frame: 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.

  15. Analgesics consumption

    Time frame: Within 30 minutes prior to PACU discharge

    The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the PACU stay

  16. Analgesics consumption

    Time frame: on postoperative day 1

    The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the first 24h after surgery

  17. Analgesics consumption

    Time frame: on postoperative day 7

    The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the week after surgery

  18. Analgesics consumption

    Time frame: 1 month postoperatively

    The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the month after surgery

  19. analgesics consumption

    Time frame: 3 months postoperatively

    The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the second and third months after surgery

  20. Postoperative complications

    Time frame: 3 months postoperatively

    Any complication in relationship with the surgery occurring during the 3 months after surgery

Other outcomes

  1. Functional recovery

    Time frame: 1 month postoperatively

    New or worsening cognitive, physical, sleeping disorders occurring during the 3 months after surgery, using binary question

  2. Functional recovery

    Time frame: 3 months postoperatively

    New or worsening cognitive, physical, sleeping disorders occurring during the 3 months after surgery, using binary question

  3. Health-related quality of life

    Time frame: 1 month postoperatively

    Health-related quality of life, assessed using a numeric rating scale

  4. Health-related quality of life

    Time frame: 3 months postoperatively

    Health-related quality of life, assessed using a numeric rating scale

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Françoise Rousseau, MD, PhD

CONTACT

[email protected]

514-934-1934

Oana Predescu, MD, PhD, MSc

CONTACT

[email protected]

514-934-1934 ext. 44604

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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