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.
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.
Canada1 site, 1 recruiting
- 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
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.
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-mastectomy pain
Brief Pain Inventory score ≥3/10
Measured: 3 months postoperatively
Secondary outcomes (20)
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
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
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Measured: on postoperative day 1
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Measured: on postoperative day 7
Acute postoperative pain
Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
Measured: 1 month postoperatively
Acute postoperative pain
postoperative opioids consumption
Measured: Within 30 minutes prior to PACU discharge
Acute postoperative pain
postoperative opioids consumption
Measured: on postoperative day 1
Acute postoperative pain
postoperative opioids consumption
Measured: on postoperative day 7
Acute postoperative pain
postoperative opioids consumption
Measured: 1 month postoperatively
postoperative nausea and vomiting
binary question
Measured: within 30 minutes prior to PACU discharge
postoperative nausea and vomiting
binary question
Measured: on postoperative day 1
postoperative nausea and vomiting
binary question
Measured: on postoperative day 7
postoperative complications
anamnesis
Measured: 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.
Measured: 3 months postoperatively
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the PACU stay
Measured: Within 30 minutes prior to PACU discharge
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the first 24h after surgery
Measured: on postoperative day 1
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the week after surgery
Measured: on postoperative day 7
Analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the month after surgery
Measured: 1 month postoperatively
analgesics consumption
The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the second and third months after surgery
Measured: 3 months postoperatively
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.
- First posted29 Apr 2026
- Study start13 Apr 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Mastectomy Chronic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Schricker, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Oana Predescu, MD, PhD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreThomas Schricker, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07556952
- Acronym / sponsor ID
- 2026-11692
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- Keywords
- dexamethasone, mastectomy, chronic pain, post-operative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone (intravenous)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 | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Participants randomized to the control group will receive a placebo, consisting of an equivalent volume of normal saline, administered intravenously at induction of anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Male sex;
- pre-existing chronic pain conditions;
- chronic opioid use;
- pregnancy or breastfeeding;
- breast surgery within the last three years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Dexamethasone |
| Normal Saline (0.9% NaCl)normal saline at a equivalent volume | Drug | Placebo |
Primary outcome
Chronic post-mastectomy pain
Time frame: 3 months postoperatively
Brief Pain Inventory score ≥3/10
20 secondary outcomes
Acute postoperative pain
Time frame: within 0-15 minutes after post-anesthesia care unit (PACU) admission
acute postoperative pain
Time frame: Within 30 minutes prior to PACU discharge
Acute postoperative pain
Time frame: on postoperative day 1
Acute postoperative pain
Time frame: on postoperative day 7
Acute postoperative pain
Time frame: 1 month postoperatively
Acute postoperative pain
Time frame: Within 30 minutes prior to PACU discharge
Acute postoperative pain
Time frame: on postoperative day 1
Acute postoperative pain
Time frame: on postoperative day 7
Acute postoperative pain
Time frame: 1 month postoperatively
postoperative nausea and vomiting
Time frame: within 30 minutes prior to PACU discharge
postoperative nausea and vomiting
Time frame: on postoperative day 1
postoperative nausea and vomiting
Time frame: on postoperative day 7
postoperative complications
Time frame: 3 months postoperatively
anxiety and depression
Time frame: 3 months postoperatively
Analgesics consumption
Time frame: Within 30 minutes prior to PACU discharge
Analgesics consumption
Time frame: on postoperative day 1
Analgesics consumption
Time frame: on postoperative day 7
Analgesics consumption
Time frame: 1 month postoperatively
analgesics consumption
Time frame: 3 months postoperatively
Postoperative complications
Time frame: 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oana Predescu, MD, PhD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Thomas Schricker, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
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.