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Dex & Mastectomy Pain

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07556952
Enrollment
170
Registered
2026-04-29
Start date
2026-04-13
Completion date
2028-06-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Mastectomy Chronic Pain Syndrome

Keywords

dexamethasone, mastectomy, chronic pain, post-operative

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.

Interventions

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.

DRUGNormal Saline (0.9% NaCl)

normal saline at a equivalent volume

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Chronic post-mastectomy pain3 months postoperativelyBrief Pain Inventory score ≥3/10

Secondary

MeasureTime frameDescription
Acute postoperative painwithin 0-15 minutes after post-anesthesia care unit (PACU) admissionNumerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
acute postoperative painWithin 30 minutes prior to PACU dischargeNumerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)
postoperative nausea and vomitingwithin 30 minutes prior to PACU dischargebinary question
postoperative complications3 months postoperativelyanamnesis
anxiety and depression3 months postoperativelyHospital 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.
Analgesics consumptionWithin 30 minutes prior to PACU dischargeThe use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the PACU stay
analgesics consumption3 months postoperativelyThe use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the second and third months after surgery
Postoperative complications3 months postoperativelyAny complication in relationship with the surgery occurring during the 3 months after surgery

Countries

Canada

Contacts

CONTACTOana Predescu, MD, PhD, MSc
oana.predescu@mcgill.ca514-934-1934
CONTACTAnne-Françoise Rousseau, MD, PhD
anne-francoise.rousseau@mcgill.ca514-934-1934
PRINCIPAL_INVESTIGATOROana Predescu, MD, PhD, MSc

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

PRINCIPAL_INVESTIGATORThomas Schricker, MD, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026