Dex & Mastectomy Pain

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Male sex;

pre-existing chronic pain conditions;

chronic opioid use;

pregnancy or breastfeeding;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: DexamethasoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Chronic post-mastectomy pain

Brief Pain Inventory score ≥3/10

Time frame
3 months postoperatively

Secondary outcomes

1

Acute postoperative pain

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

Time frame
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)

Time frame
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)

Time frame
on postoperative day 1
4

Acute postoperative pain

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

Time frame
on postoperative day 7

Other outcomes

1

Functional recovery

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

Time frame
1 month postoperatively
2

Functional recovery

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

Time frame
3 months postoperatively
3

Health-related quality of life

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

Time frame
1 month postoperatively
4

Health-related quality of life

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

Time frame
3 months postoperatively

Sponsors and contacts

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