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Post-Mastectomy Chronic Pain SyndromePhase 4NCT07556952

Dex & Mastectomy Pain

A Phase 4 study testing Dexamethasone (intravenous) and Normal Saline (0.9% NaCl) in people with Post-Mastectomy Chronic Pain Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Post-Mastectomy Chronic Pain Syndrome
What is being tested?
Dexamethasone (intravenous) and Normal Saline (0.9% NaCl)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
1 siteCanada
Study dates
13 Apr 2026to 30 Jun 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oana Predescu, MD, PhD, MSc contact

514-934-1934 ext. 44604

oana.predescu@mcgill.ca

Anne-Françoise Rousseau, MD, PhD contact

514-934-1934

anne-francoise.rousseau@mcgill.ca

Canada1 site, 1 recruiting
  • McGill University Health Centre (MUHC)

    Montreal, Quebec

    Oana Predescu, MD, PhD, MSc, 514-934-1934 ext. 44604, oana.predescu@mcgill.ca

    Anne-Françoise Rousseau, MD, PhD, 514-934-1934, anne-francoise.rousseau@mcgill.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Being tested
Dexamethasone (intravenous), Normal Saline (0.9% NaCl)
Keywords
dexamethasone, mastectomy, chronic pain, post-operative
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07556952
Study groupRoleWhat they receive
DexamethasoneExperimentalParticipants 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.
Receives: Drug: Dexamethasone (intravenous)
PlaceboPlacebo comparatorParticipants randomized to the control group will receive a placebo, consisting of an equivalent volume of normal saline, administered intravenously at induction of anesthesia.
Receives: Drug: Normal Saline (0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic post-mastectomy pain

    Brief Pain Inventory score ≥3/10

    Measured: 3 months postoperatively

Secondary outcomes (20)
  1. Acute postoperative pain

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

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

  2. acute postoperative pain

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

    Measured: Within 30 minutes prior to PACU discharge

  3. Acute postoperative pain

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

    Measured: on postoperative day 1

  4. Acute postoperative pain

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

    Measured: on postoperative day 7

  5. Acute postoperative pain

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

    Measured: 1 month postoperatively

  6. Acute postoperative pain

    postoperative opioids consumption

    Measured: Within 30 minutes prior to PACU discharge

  7. Acute postoperative pain

    postoperative opioids consumption

    Measured: on postoperative day 1

  8. Acute postoperative pain

    postoperative opioids consumption

    Measured: on postoperative day 7

  9. Acute postoperative pain

    postoperative opioids consumption

    Measured: 1 month postoperatively

  10. postoperative nausea and vomiting

    binary question

    Measured: within 30 minutes prior to PACU discharge

  11. postoperative nausea and vomiting

    binary question

    Measured: on postoperative day 1

  12. postoperative nausea and vomiting

    binary question

    Measured: on postoperative day 7

  13. postoperative complications

    anamnesis

    Measured: 3 months postoperatively

  14. 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.

    Measured: 3 months postoperatively

  15. Analgesics consumption

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

    Measured: Within 30 minutes prior to PACU discharge

  16. Analgesics consumption

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

    Measured: on postoperative day 1

  17. Analgesics consumption

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

    Measured: on postoperative day 7

  18. Analgesics consumption

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

    Measured: 1 month postoperatively

  19. analgesics consumption

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

    Measured: 3 months postoperatively

  20. Postoperative complications

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

    Measured: 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start13 Apr 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556952
Sponsor's protocol ID
2026-11692
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone (intravenous) and Normal Saline (0.9% NaCl) in people with Post-Mastectomy Chronic Pain Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oana Predescu, MD, PhD, MSc (514-934-1934 ext. 44604, oana.predescu@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic post-mastectomy pain (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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